Study of MK-4166 and MK-4166 in Combination With Pembroli... | NCT02132754 | Trialant
NCT02132754
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Jan 28, 2021Actual
Enrollment
116Actual
Phase
Phase 1
Conditions
Solid Tumor
Interventions
MK-4166
Pembrolizumab
Countries
Not provided
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT02132754
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
4166-001
Secondary IDs
ID
Type
Description
Link
MK-4166-001
Other Identifier
Merck
Brief Title
Study of MK-4166 and MK-4166 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-4166-001)
Official Title
Phase 1 Trial of Single Agent MK-4166 and MK-4166 in Combination With Pembrolizumab in Subjects With Advanced Malignancies
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Jan 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 27, 2014Actual
Primary Completion Date
Jul 31, 2019Actual
Completion Date
Jul 31, 2019Actual
First Submitted Date
May 5, 2014
First Submission Date that Met QC Criteria
May 5, 2014
First Posted Date
May 7, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 13, 2020
Results First Submitted that Met QC Criteria
Jul 13, 2020
Results First Posted Date
Jul 31, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 12, 2021
Last Update Posted Date
Jan 28, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is planned to be a 5-part dose-escalation study to determine the safety and tolerability of MK-4166 monotherapy and MK-4166 plus pembrolizumab combination therapy, and to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD) of MK-4166 and MK-4166 plus pembrolizumab by defining dose-limiting toxicities (DLTs) in participants with advanced solid tumors.
Detailed Description
In Part A, MK-4166 doses will be escalated quickly in successive cohorts and based on safety events may progress to Part B, in which the preliminary MTD will be identified. Based on safety events the study may progress to Part C in which the MTD will be confirmed. In Part D, participants will receive escalating doses of MK-4166 plus a fixed dose of pembrolizumab (MK-3475) 200 mg to determine the MTD for MK-4166 in combination with pembrolizumab. Based on safety events in Part D, the study may progress to Part E in which the MTD for MK-4166 in combination with pembrolizumab will be confirmed.
With Amendments 05/06, the dose confirmation Part C will be removed and the dose confirmation Part E (combination of MK-4166 and pembrolizumab) will be limited to participants with advanced malignant melanoma.
Conditions Module
Conditions
Solid Tumor
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
116Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
MK-4166 0.0015 mg
Experimental
Participant received 0.0015 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
Biological: MK-4166
MK-4166 0.0045 mg
Experimental
Participant received 0.0045 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
Biological: MK-4166
MK-4166 0.014 mg
Experimental
Participant received 0.014 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
Biological: MK-4166
MK-4166 0.04 mg
Experimental
Participant received 0.04 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
Biological: MK-4166
MK-4166 0.12 mg
Experimental
Participant received 0.12 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
Biological: MK-4166
MK-4166 0.37 mg
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MK-4166
Biological
MK-4166 0.0015 mg
MK-4166 0.0045 mg
MK-4166 0.014 mg
MK-4166 0.04 mg
MK-4166 0.12 mg
MK-4166 0.37 mg
MK-4166 1.1 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
DLT's were assessed during the first cycle (21 days) for each dose level and included the following if assessed by the Investigator to be possibly, probably or definitely related to MK-4166 or MK-4166 plus pembrolizumab combination: Grade 4 non-hematologic toxicity; Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia (Grade 4 thrombocytopenia of any duration or Grade 3 thrombocytopenia if associated with bleeding); Grade 3 non-hematologic toxicity lasting >3 days despite optimal supportive care; Grade 3 nausea, vomiting or diarrhea if >3 days despite optimal supportive care; any Grade 3 or Grade 4 non-hematologic laboratory abnormality if medical intervention is required or if leading to hospitalization or if persisting for >1 week; febrile neutropenia Grade 3 or Grade 4; any drug-related AE which caused participant to discontinue treatment during Cycle 1; Grade 5 toxicity; any treatment-related toxicity which caused a >2 week delay in initiation of Cycle 2.
Cycle 1 (up to 21 days)
Number of Participants Experiencing Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE.
Per protocol, the number of participants experiencing an AE was assessed and reported by arm (MK-4166 monotherapy and MK-4166 plus pembrolizumab combination therapy) as well as by dose cohort.
From first dose up to 90 days post last dose (up to 27 months)
Number of Participants Discontinuing Study Treatment Due to AEs
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE.
Per protocol, the number of participants discontinuing study treatment due to AEs was assessed and reported by arm (MK-4166 monotherapy and MK-4166 plus pembrolizumab combination therapy) as well as by dose cohort.
Secondary Outcomes
Measure
Description
Time Frame
Maximum Concentration (Cmax) of MK-4166 Over Time
Blood samples were collected at pre-specified time points during Cycles 1-4 and plasma isolated for analysis of MK-4166 Cmax. Cmax was defined as the maximum concentration of MK-4166 reached. MK-4166 Cmax was reported by dose cohort. Per protocol, percent geometric coefficient of variation (%GCV) values were not reported for cohorts with n<2 participants.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria:
Has a histologically- or cytologically-confirmed metastatic solid tumor for which there is no available therapy which may convey clinical benefit. Part E: Has advanced malignant melanoma.
Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
Adequate organ function
Female participants of childbearing potential must have a negative urine or serum pregnancy test and must be surgically sterile or willing to use 2 methods of birth control or abstain from heterosexual activity for the course of the study through 120 days after last dose of study drug
Male participants must agree to use an adequate method of contraception during sexual contact with females of childbearing potential starting with the first dose of study drug through 180 days after the last dose of study drug
Submit an evaluable tumor sample for analysis.
Exclusion criteria:
Chemotherapy, radiation, or biological cancer therapy within 4 weeks prior to the first dose of study drug, or who has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better from the adverse events due to cancer therapeutics administered more than 4 weeks earlier
Currently participating or has participated in a study of an investigational agent or using an investigational device within 28 days of administration of MK-4166
Expected to require any other form of antineoplastic therapy while on study
On chronic systemic steroid therapy in excess of replacement doses, or on any other form of immunosuppressive medication
History of a malignancy for which potentially curative treatment has been completed, with no evidence of malignancy for 5 years excepting successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, or in situ cervical cancer
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Severe hypersensitivity reaction to treatment with another monoclonal antibody
Active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved childhood asthma/atopy
Active infection requiring therapy
Current pneumonitis, or a history of (non-infectious) pneumonitis that required steroids
Prior stem cell or bone marrow transplant
Positive for human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Regular user (including "recreational use") of any illicit drugs or recent history (within the last year) of substance abuse (including alcohol)
Symptomatic ascites or pleural effusion
Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study
Clinically significant heart disease
Major surgery in the past 16 weeks
Received a live vaccine within 30 days prior to first dose of study drug
Papadopoulos KP, Autio K, Golan T, Dobrenkov K, Chartash E, Chen Q, Wnek R, Long GV. Phase I Study of MK-4166, an Anti-human Glucocorticoid-Induced TNF Receptor Antibody, Alone or with Pembrolizumab in Advanced Solid Tumors. Clin Cancer Res. 2021 Apr 1;27(7):1904-1911. doi: 10.1158/1078-0432.CCR-20-2886. Epub 2020 Dec 21.
Of 116 participants that were non-randomly allocated to treatment, 113 participants received treatment and were evaluable for all analyses.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
MK-4166 0.0015 mg
Participant received 0.0015 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
FG001
MK-4166 0.0045 mg
Participant received 0.0045 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
FG002
MK-4166 0.014 mg
Participant received 0.014 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
FG003
MK-4166 0.04 mg
Participant received 0.04 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
FG004
MK-4166 0.12 mg
Participant received 0.12 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
FG005
MK-4166 0.37 mg
Participant received 0.37 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
FG006
MK-4166 1.1 mg
Participant received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
FG007
MK-4166 3.3 mg
Participant received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
FG008
MK-4166 10 mg
Participant received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
FG009
MK-4166 30 mg
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
FG010
MK-4166 42 mg
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
FG011
MK-4166 59 mg
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
FG012
MK-4166 82 mg
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
FG013
MK-4166 120 mg
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
FG014
MK-4166 170 mg
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
FG015
MK-4166 240 mg
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
FG016
MK-4166 340 mg
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
FG017
MK-4166 480 mg
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
FG018
MK-4166 670 mg
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
FG019
MK-4166 900 mg
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
FG020
MK-4166 1.1 mg + Pembro
Participants received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
FG021
MK-4166 3.3 mg + Pembro
Participants received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
FG022
MK-4166 10 mg + Pembro
Participants received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
FG023
MK-4166 30 mg + Pembro
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
FG024
MK-4166 42 mg + Pembro
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
FG025
MK-4166 59 mg + Pembro
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
FG026
MK-4166 82 mg + Pembro
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
FG027
MK-4166 120 mg + Pembro
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
FG028
MK-4166 170 mg + Pembro
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
FG029
MK-4166 240 mg + Pembro
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
FG030
MK-4166 340 mg + Pembro
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
FG031
MK-4166 480 mg + Pembro
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
FG032
MK-4166 670 mg + Pembro
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
FG033
MK-4166 900 mg + Pembro
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG0041 subjects
FG0051 subjects
FG0061 subjects
FG0071 subjects
FG0081 subjects
FG0096 subjects
FG0103 subjects
FG0113 subjects
FG0124 subjects
FG0133 subjects
FG0143 subjects
FG0155 subjects
FG0164 subjects
FG0173 subjects
FG0183 subjects
FG0194 subjects
FG0203 subjects
FG0215 subjects
FG0223 subjects
FG0233 subjects
FG0243 subjects
FG0253 subjects
FG0264 subjects
FG0273 subjects
FG0283 subjects
FG0293 subjects
FG0303 subjects
FG0313 subjects
FG0324 subjects
FG03323 subjects
Treated
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG004
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
MK-4166 0.0015 mg
Participant received 0.0015 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
BG001
MK-4166 0.0045 mg
Participant received 0.0045 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
DLT's were assessed during the first cycle (21 days) for each dose level and included the following if assessed by the Investigator to be possibly, probably or definitely related to MK-4166 or MK-4166 plus pembrolizumab combination: Grade 4 non-hematologic toxicity; Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia (Grade 4 thrombocytopenia of any duration or Grade 3 thrombocytopenia if associated with bleeding); Grade 3 non-hematologic toxicity lasting >3 days despite optimal supportive care; Grade 3 nausea, vomiting or diarrhea if >3 days despite optimal supportive care; any Grade 3 or Grade 4 non-hematologic laboratory abnormality if medical intervention is required or if leading to hospitalization or if persisting for >1 week; febrile neutropenia Grade 3 or Grade 4; any drug-related AE which caused participant to discontinue treatment during Cycle 1; Grade 5 toxicity; any treatment-related toxicity which caused a >2 week delay in initiation of Cycle 2.
All allocated participants who received at least 1 dose of study treatment and were evaluable for DLTs in Cycle 1.
Posted
Number
Participants
Cycle 1 (up to 21 days)
Adverse Events Module
Frequency Threshold
0
Time Frame
Up to approximately 61 months (through final cut-off date of 31-Jul-2019)
Description
All-Cause Mortality table includes all allocated participants.
Serious and Other adverse events (AEs) include all allocated participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer on study not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data reported by treatment arm and by dose cohort
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
MK-4166
All participants that received MK-4166 IV on Day 1 of each 21-day cycle, for up to 4 cycles (according to assigned dose).
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cardiac failure
Cardiac disorders
MedDRA 22.1
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Participant received 0.37 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
Biological: MK-4166
MK-4166 1.1 mg
Experimental
Participant received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
Biological: MK-4166
MK-4166 3.3 mg
Experimental
Participant received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
Biological: MK-4166
MK-4166 10 mg
Experimental
Participant received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
Biological: MK-4166
MK-4166 30 mg
Experimental
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
Biological: MK-4166
MK-4166 42 mg
Experimental
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
Biological: MK-4166
MK-4166 59 mg
Experimental
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
Biological: MK-4166
MK-4166 82 mg
Experimental
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
Biological: MK-4166
MK-4166 120 mg
Experimental
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
Biological: MK-4166
MK-4166 170 mg
Experimental
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
Biological: MK-4166
MK-4166 240 mg
Experimental
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
Biological: MK-4166
MK-4166 340 mg
Experimental
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
Biological: MK-4166
MK-4166 480 mg
Experimental
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
Biological: MK-4166
MK-4166 670 mg
Experimental
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
Biological: MK-4166
MK-4166 900 mg
Experimental
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
Biological: MK-4166
MK-4166 1.1 mg + Pembro
Experimental
Participants received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
Biological: MK-4166
Biological: Pembrolizumab
MK-4166 3.3 mg + Pembro
Experimental
Participants received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
Biological: MK-4166
Biological: Pembrolizumab
MK-4166 10 mg + Pembro
Experimental
Participants received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
Biological: MK-4166
Biological: Pembrolizumab
MK-4166 30 mg + Pembro
Experimental
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
Biological: MK-4166
Biological: Pembrolizumab
MK-4166 42 mg + Pembro
Experimental
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
Biological: MK-4166
Biological: Pembrolizumab
MK-4166 59 mg + Pembro
Experimental
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
Biological: MK-4166
Biological: Pembrolizumab
MK-4166 82 mg + Pembro
Experimental
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
Biological: MK-4166
Biological: Pembrolizumab
MK-4166 120 mg + Pembro
Experimental
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
Biological: MK-4166
Biological: Pembrolizumab
MK-4166 170 mg + Pembro
Experimental
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
Biological: MK-4166
Biological: Pembrolizumab
MK-4166 240 mg + Pembro
Experimental
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
Biological: MK-4166
Biological: Pembrolizumab
MK-4166 340 mg + Pembro
Experimental
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
Biological: MK-4166
Biological: Pembrolizumab
MK-4166 480 mg + Pembro
Experimental
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
Biological: MK-4166
Biological: Pembrolizumab
MK-4166 670 mg + Pembro
Experimental
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
Biological: MK-4166
Biological: Pembrolizumab
MK-4166 900 mg + Pembro
Experimental
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
Biological: MK-4166
Biological: Pembrolizumab
MK-4166 1.1 mg + Pembro
MK-4166 10 mg
MK-4166 10 mg + Pembro
MK-4166 120 mg
MK-4166 120 mg + Pembro
MK-4166 170 mg
MK-4166 170 mg + Pembro
MK-4166 240 mg
MK-4166 240 mg + Pembro
MK-4166 3.3 mg
MK-4166 3.3 mg + Pembro
MK-4166 30 mg
MK-4166 30 mg + Pembro
MK-4166 340 mg
MK-4166 340 mg + Pembro
MK-4166 42 mg
MK-4166 42 mg + Pembro
MK-4166 480 mg
MK-4166 480 mg + Pembro
MK-4166 59 mg
MK-4166 59 mg + Pembro
MK-4166 670 mg
MK-4166 670 mg + Pembro
MK-4166 82 mg
MK-4166 82 mg + Pembro
MK-4166 900 mg
MK-4166 900 mg + Pembro
Pembrolizumab
Biological
MK-4166 1.1 mg + Pembro
MK-4166 10 mg + Pembro
MK-4166 120 mg + Pembro
MK-4166 170 mg + Pembro
MK-4166 240 mg + Pembro
MK-4166 3.3 mg + Pembro
MK-4166 30 mg + Pembro
MK-4166 340 mg + Pembro
MK-4166 42 mg + Pembro
MK-4166 480 mg + Pembro
MK-4166 59 mg + Pembro
MK-4166 670 mg + Pembro
MK-4166 82 mg + Pembro
MK-4166 900 mg + Pembro
Up to approximately 24 months
Cycles 1-4: Day 1 pre-dose, at end of MK-4166 infusion (up to 10 minutes), 2 hours; Days 2, 3, 5 (Cohorts 1-9 only), 8, 15. Each cycle was 21 days. (Up to ~3 months)
Time to Maximum Concentration (Tmax) of MK-4166 Over Time
Blood samples were collected at pre-specified time points during Cycles 1-4 and plasma isolated for analysis of MK-4166 Tmax. Tmax was defined as time to the maximum concentration of MK-4166 reached. MK-4166 Tmax was reported by dose cohort.
Cycles 1-4: Day 1 pre-dose, at end of MK-4166 infusion (up to 10 minutes), 2 hours; Days 2, 3, 5 (Cohorts 1-9 only), 8, 15. Each cycle was 21 days. (Up to ~3 months)
Terminal Half-Life (t ½) of MK-4166 Over Time
Blood samples were collected at pre-specified time points during Cycles 1-4 and plasma isolated for analysis of MK-4166 t½. t½ was defined as the time required to divide the MK-4166 plasma concentration by two after reaching pseudo-equilibrium, following a single dose of MK-4166. MK-4166 t½ was reported by dose cohort. Per protocol, % GCV values were not reported for cohorts with n<2 participants.
Cycles 1-4: Day 1 pre-dose, at end of MK-4166 infusion (up to 10 minutes), 2 hours; Days 2, 3, 5 (Cohorts 1-9 only), 8, 15. Each cycle was 21 days. (Up to ~3 months)
Area Under the Concentration-Time Curve of MK-4166 From Time Zero to 21 Hours After Dosing (AUC 0-21) Over Time
Blood samples were collected at pre-specified time points during Cycles 1-4 and plasma isolated for analysis of MK-4166 AUC0-21. AUC0-21 was defined as the area under the concentration-time curve of MK-4166 from time zero to 21 hours after dosing. MK-4166 AUC0-21 was reported by dose cohort. Per protocol, % GCV values were not reported for cohorts with n<2 participants.
Cycles 1-4: Day 1 pre-dose, at end of MK-4166 infusion (up to 10 minutes), 2 hours; Day 2. Each cycle was 21 days. (Up to ~3 months)
Area Under the Concentration-Time Curve of MK-4166 From Time Zero to The Last Quantifiable Sample (AUC 0-last) Over Time
Blood samples were collected at pre-specified time points during Cycles 1-4 and plasma isolated for analysis of MK-4166 AUC0-last. AUC0-last was defined as the area under the concentration-time curve of MK-4166 from time zero to the last quantifiable sample. MK-4166 AUC0-last was reported by dose cohort. Per protocol, % GCV values were not reported for cohorts with n<2 participants.
Cycles 1-4: Day 1 pre-dose, at end of MK-4166 infusion (up to 10 minutes), 2 hours; Days 2, 3, 5 (Cohorts 1-9 only), 8, 15. Each cycle was 21 days. (Up to ~3 months)
Area Under the Concentration-Time Curve of MK-4166 From Time Zero to Infinity (AUC 0-inf) Over Time
Blood samples were collected at pre-specified time points during Cycles 1-4 and plasma isolated for analysis of MK-4166 AUC0-inf. AUC0-inf was defined as the area under the concentration-time curve of MK-4166 from time zero to infinity. MK-4166 AUC0-inf was reported by dose cohort. Per protocol, % GCV values were not reported for cohorts with n<2 participants.
Cycles 1-4: Day 1 pre-dose, at end of MK-4166 infusion (up to 10 minutes), 2 hours; Days 2, 3, 5 (Cohorts 1-9 only), 8, 15. Each cycle was 21 days. (Up to ~3 months)
Apparent Clearance (CL) of MK-4166 Over Time
Blood samples were collected at pre-specified time points during Cycles 1-4 and plasma isolated for analysis of MK-4166 CL. CL was defined as the volume of plasma from which MK-4166 is eliminated per unit time following IV MK-4166 administration. MK-4166 CL was reported by dose cohort. Per protocol, % GCV values were not reported for cohorts with n<2 participants.
Cycles 1-4: Day 1 pre-dose, at end of MK-4166 infusion (up to 10 minutes), 2 hours; Days 2, 3, 5 (Cohorts 1-9 only), 8, 15. Each cycle was 21 days. (Up to ~3 months)
Apparent Volume of Distribution (V) of MK-4166 Over Time
Blood samples were collected at pre-specified time points during Cycles 1-4 and plasma isolated for analysis of MK-4166 V. V was defined as the theoretical volume that would be necessary to contain the total amount of administered MK-4166 at the same concentration that it is observed in the blood plasma. MK-4166 V was reported by dose cohort. Per protocol, % GCV values were not reported for cohorts with n<2 participants.
Cycles 1-4: Day 1 pre-dose, at end of MK-4166 infusion (up to 10 minutes), 2 hours; Days 2, 3, 5 (Cohorts 1-9 only), 8, 15. Each cycle was 21 days. (Up to ~3 months)
Maximum Concentration (Cmax) of Pembrolizumab Over Time
Blood samples were collected at pre-specified time points during Cycles 1-4 from MK-4166 plus pembrolizumab combination cohorts only and plasma isolated for analysis of pembrolizumab Cmax. Cmax was defined as the maximum concentration of pembrolizumab reached. Pembrolizumab Cmax was reported by dose cohort for all participants that received MK-4166 plus pembrolizumab combination therapy. Per protocol, participants receiving MK-4166 monotherapy were excluded from this analysis.
Cycles 1-4: Day 1 pre-dose, at end of pembro infusion (up to 10 minutes), at end of MK-4166 infusion (up to 10 minutes), ~2 hours after start of MK-4166 infusion, Days 2, 3, 8, 15. Each cycle was 21 days. (Up to ~3 months)
Time to Maximum Concentration (Tmax) of Pembrolizumab Over Time
Blood samples were collected at pre-specified time points during Cycles 1-4 from MK-4166 plus pembrolizumab combination cohorts only and plasma isolated for analysis of pembrolizumab Tmax. Tmax was defined as time to the maximum concentration of pembrolizumab reached. Pembrolizumab Tmax was reported by dose cohort for all participants that received MK-4166 plus pembrolizumab combination therapy. Per protocol, participants receiving MK-4166 monotherapy were excluded from this analysis.
Cycles 1-4: Day 1 pre-dose, at end of pembro infusion (up to 10 minutes), at end of MK-4166 infusion (up to 10 minutes), ~2 hours after start of MK-4166 infusion, Days 2, 3, 8, 15. Each cycle was 21 days. (Up to ~3 months)
Terminal Half-Life (t ½) of Pembrolizumab Over Time
Blood samples were collected at pre-specified time points during Cycles 1-4 from MK-4166 plus pembrolizumab combination cohorts only and plasma isolated for analysis of pembrolizumab t½. t½ was defined as the time required to divide the pembrolizumab plasma concentration by two after reaching pseudo-equilibrium, following a single dose of pembrolizumab. Pembrolizumab t½ was reported by dose cohort for all participants that received MK-4166 plus pembrolizumab combination therapy. Per protocol, participants receiving MK-4166 monotherapy were excluded from this analysis.
Cycles 1-4: Day 1 pre-dose, at end of pembro infusion (up to 10 minutes), at end of MK-4166 infusion (up to 10 minutes), ~2 hours after start of MK-4166 infusion, Days 2, 3, 8, 15. Each cycle was 21 days. (Up to ~3 months)
Area Under the Concentration-Time Curve of Pembrolizumab From Time Zero to 21 Hours After Dosing (AUC 0-21) Over Time
Blood samples were collected at pre-specified time points during Cycles 1-4 from MK-4166 plus pembrolizumab combination cohorts only and plasma isolated for analysis of pembrolizumab AUC0-21. AUC0-21 was defined as the area under the concentration-time curve of pembrolizumab from time zero to 21 hours after dosing. Pembrolizumab AUC0-21 was reported by dose cohort for all participants that received MK-4166 plus pembrolizumab combination therapy. Per protocol, participants receiving MK-4166 monotherapy were excluded from this analysis.
Cycles 1-4: Day 1 pre-dose, at end of pembro infusion (up to 10 minutes), at end of MK-4166 infusion (up to 10 minutes), ~2 hours after start of MK-4166 infusion, Day 2. Each cycle was 21 days. (Up to ~3 months)
Area Under the Concentration-Time Curve of Pembrolizumab From Time Zero to The Last Quantifiable Sample (AUC 0-last) Over Time
Blood samples were collected at pre-specified time points during Cycles 1-4 from MK-4166 plus pembrolizumab combination cohorts only and plasma isolated for analysis of pembrolizumab AUC0-last. AUC0-last was defined as the area under the concentration-time curve of pembrolizumab from time zero to the last quantifiable sample. Pembrolizumab AUC0-last was reported by dose cohort for all participants that received MK-4166 plus pembrolizumab combination therapy. Per protocol, participants receiving MK-4166 monotherapy were excluded from this analysis.
Cycles 1-4: Day 1 pre-dose, at end of pembro infusion (up to 10 minutes), at end of MK-4166 infusion (up to 10 minutes), ~2 hours after start of MK-4166 infusion, Days 2, 3, 8, 15. Each cycle was 21 days. (Up to ~3 months)
Area Under the Concentration-Time Curve of Pembrolizumab From Time Zero to Infinity (AUC 0-inf) Over Time
Blood samples were collected at pre-specified time points during Cycles 1-4 from MK-4166 plus pembrolizumab combination cohorts only and plasma isolated for analysis of pembrolizumab AUC0-inf. AUC0-inf was defined as the area under the concentration-time curve of pembrolizumab from time zero to infinity. Pembrolizumab AUC0-inf was reported by dose cohort for all participants that received MK-4166 plus pembrolizumab combination therapy. Per protocol, participants receiving MK-4166 monotherapy were excluded from this analysis.
Cycles 1-4: Day 1 pre-dose, at end of pembro infusion (up to 10 minutes), at end of MK-4166 infusion (up to 10 minutes), ~2 hours after start of MK-4166 infusion, Days 2, 3, 8, 15. Each cycle was 21 days. (Up to ~3 months)
Apparent Clearance (CL) of Pembrolizumab Over Time
Blood samples were collected at pre-specified time points during Cycles 1-4 from MK-4166 plus pembrolizumab combination cohorts only and plasma isolated for analysis of pembrolizumab CL. CL was defined as the volume of plasma from which pembrolizumab is eliminated per unit time following IV pembrolizumab administration. Pembrolizumab CL was reported by dose cohort for all participants that received MK-4166 plus pembrolizumab combination therapy. Per protocol, participants receiving MK-4166 monotherapy were excluded from this analysis.
Cycles 1-4: Day 1 pre-dose, at end of pembro infusion (up to 10 minutes), at end of MK-4166 infusion (up to 10 minutes), ~2 hours after start of MK-4166 infusion, Days 2, 3, 8, 15. Each cycle was 21 days. (Up to ~3 months)
Apparent Volume of Distribution (V) of Pembrolizumab Over Time
Blood samples were collected at pre-specified time points during Cycles 1-4 from MK-4166 plus pembrolizumab combination cohorts only and plasma isolated for analysis of pembrolizumab V. V was defined as the theoretical volume that would be necessary to contain the total amount of administered pembrolizumab at the same concentration that it is observed in the blood plasma. Pembrolizumab V was reported by dose cohort for all participants that received MK-4166 plus pembrolizumab combination therapy. Per protocol, participants receiving MK-4166 monotherapy were excluded from this analysis.
Cycles 1-4: Day 1 pre-dose, at end of pembro infusion (up to 10 minutes), at end of MK-4166 infusion (up to 10 minutes), ~2 hours after start of MK-4166 infusion, Days 2, 3, 8, 15. Each cycle was 21 days. (Up to ~3 months)
Glucocorticoid-Induced Tumor Necrosis Factor Receptor-Related Protein (GITR) Receptor Availability Following MK-4166 Administration
GITR protein receptor is internalized upon binding by MK-4166. To evaluate GITR target engagement, a GITR receptor availability assay was developed to assess the availability of cell surface GITR following administration of MK-4166. GITR was detected on CD4+CD25+ and CD4+CD95+ T-cell sub-populations in peripheral blood using flow cytometry. GITR receptor availability on representative CD4+ CD25+ T cell subsets following MK-4166 administration was reported over time for each dose cohort.
Cycle 1 Day 1: at end of infusion (up to 10 minutes), 2 hours post-infusion, Cycle 1 Days 2, 3, 5, 8, 15, Cycle 2 Day 1 pre-dose. Each cycle was 21 days.
1 subjects
FG0051 subjects
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0 subjects
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1 subjects
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0 subjects
FG0040 subjects
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FG0090 subjects
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FG0200 subjects
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FG0240 subjects
FG0251 subjects
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FG0301 subjects
FG0310 subjects
FG0321 subjects
FG0331 subjects
Clinical Progression
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
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FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
FG0110 subjects
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FG0200 subjects
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FG0241 subjects
FG0251 subjects
FG0260 subjects
FG0271 subjects
FG0281 subjects
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FG0301 subjects
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Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
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FG0170 subjects
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FG0200 subjects
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FG0240 subjects
FG0250 subjects
FG0261 subjects
FG0270 subjects
FG0280 subjects
FG0290 subjects
FG0300 subjects
FG0310 subjects
FG0320 subjects
FG0332 subjects
Excluded Medication
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
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FG0190 subjects
FG0201 subjects
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FG0260 subjects
FG0270 subjects
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FG0331 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
FG0111 subjects
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FG0270 subjects
FG0280 subjects
FG0290 subjects
FG0300 subjects
FG0311 subjects
FG0320 subjects
FG0333 subjects
Progressive Disease
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG0041 subjects
FG0051 subjects
FG0061 subjects
FG0071 subjects
FG0081 subjects
FG0093 subjects
FG0103 subjects
FG0112 subjects
FG0122 subjects
FG0133 subjects
FG0142 subjects
FG0151 subjects
FG0162 subjects
FG0171 subjects
FG0183 subjects
FG0191 subjects
FG0201 subjects
FG0213 subjects
FG0222 subjects
FG0233 subjects
FG0240 subjects
FG0251 subjects
FG0262 subjects
FG0271 subjects
FG0282 subjects
FG0293 subjects
FG0301 subjects
FG0311 subjects
FG0323 subjects
FG0336 subjects
Screen Failure
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0191 subjects
FG0200 subjects
FG0211 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 subjects
FG0260 subjects
FG0270 subjects
FG0280 subjects
FG0290 subjects
FG0300 subjects
FG0310 subjects
FG0320 subjects
FG0330 subjects
Transferred to Extension Study
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 subjects
FG0260 subjects
FG0270 subjects
FG0280 subjects
FG0290 subjects
FG0300 subjects
FG0310 subjects
FG0320 subjects
FG0336 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
FG0110 subjects
FG0121 subjects
FG0130 subjects
FG0141 subjects
FG0152 subjects
FG0161 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0201 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
FG0241 subjects
FG0250 subjects
FG0260 subjects
FG0271 subjects
FG0280 subjects
FG0290 subjects
FG0300 subjects
FG0311 subjects
FG0320 subjects
FG0332 subjects
BG002
MK-4166 0.014 mg
Participant received 0.014 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
BG003
MK-4166 0.04 mg
Participant received 0.04 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
BG004
MK-4166 0.12 mg
Participant received 0.12 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
BG005
MK-4166 0.37 mg
Participant received 0.37 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
BG006
MK-4166 1.1 mg
Participant received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
BG007
MK-4166 3.3 mg
Participant received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
BG008
MK-4166 10 mg
Participant received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
BG009
MK-4166 30 mg
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
BG010
MK-4166 42 mg
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
BG011
MK-4166 59 mg
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
BG012
MK-4166 82 mg
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
BG013
MK-4166 120 mg
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
BG014
MK-4166 170 mg
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
BG015
MK-4166 240 mg
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
BG016
MK-4166 340 mg
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
BG017
MK-4166 480 mg
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
BG018
MK-4166 670 mg
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
BG019
MK-4166 900 mg
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
BG020
MK-4166 1.1 mg + Pembro
Participants received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
BG021
MK-4166 3.3 mg + Pembro
Participants received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
BG022
MK-4166 10 mg + Pembro
Participants received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
BG023
MK-4166 30 mg + Pembro
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
BG024
MK-4166 42 mg + Pembro
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
BG025
MK-4166 59 mg + Pembro
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
BG026
MK-4166 82 mg + Pembro
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
BG027
MK-4166 120 mg + Pembro
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
BG028
MK-4166 170 mg + Pembro
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
BG029
MK-4166 240 mg + Pembro
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
BG030
MK-4166 340 mg + Pembro
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
BG031
MK-4166 480 mg + Pembro
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
BG032
MK-4166 670 mg + Pembro
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
BG033
MK-4166 900 mg + Pembro
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
BG034
Total
Total of all reporting groups
1
BG0011
BG0021
BG0031
BG0041
BG0051
BG0061
BG0071
BG0081
BG0096
BG0103
BG0113
BG0124
BG0133
BG0143
BG0155
BG0164
BG0173
BG0183
BG0194
BG0203
BG0215
BG0223
BG0233
BG0243
BG0253
BG0264
BG0273
BG0283
BG0293
BG0303
BG0313
BG0324
BG03323
BG034116
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00045.0± 0
BG00150.0± 0
BG00243.0± 0
BG00347.0± 0
BG00474.0± 0
BG00565.0± 0
BG00672.0± 0
BG00773.0± 0
BG00850.0± 0
BG00964.7± 9.3
BG01057.3± 7.1
BG01154.3± 12.6
BG01266.8± 22.5
BG01361.7± 4.2
BG01462.0± 11.8
BG01564.6± 11.7
BG01666.0± 9.7
BG01766.7± 12.1
BG01864.0± 12.2
BG01971.8± 9.3
BG02060.3± 7.0
BG02152.2± 17.2
BG02258.0± 11.4
BG02348.3± 25.5
BG02452.3± 3.8
BG02574.0± 6.2
BG02649.0± 23.2
BG02756.3± 11.2
BG02863.0± 9.8
BG02949.7± 25.1
BG03052.7± 17.6
BG03163.3± 24.7
BG03260.5± 20.5
BG03362.0± 15.6
BG03460.4± 14.6
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG0020
BG0031
BG0041
BG0051
BG0061
BG0071
BG0080
BG0093
BG0101
BG0113
BG0123
BG0131
BG0142
BG0151
BG0162
BG0172
BG0181
BG0193
BG0202
BG0211
BG0222
BG0232
BG0242
BG0252
BG0263
BG0273
BG0282
BG0292
BG0301
BG0312
BG0321
BG0336
BG03458
Male
BG0001
BG0011
BG0021
BG0030
BG004
Ethnicity (NIH/OMB)
0 participants are reported due to the risk of identification of a person.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
BG0190
BG0200
BG0210
BG0220
BG0230
BG0240
BG0250
BG0260
BG0270
BG0280
BG0290
BG0300
BG0310
BG0320
BG0330
BG0340
Not Hispanic or Latino
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0001
BG0011
BG0021
BG0031
BG004
Race (NIH/OMB)
0 participants are reported due to the risk of identification of a person.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
BG0190
BG0200
BG0210
BG0220
BG0230
BG0240
BG0250
BG0260
BG0270
BG0280
BG0290
BG0300
BG0310
BG0320
BG0330
BG0340
Asian
BG0000
BG0010
BG0020
BG0030
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0000
BG0010
BG0020
BG0030
BG004
White
BG0000
BG0010
BG0020
BG0030
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0001
BG0011
BG0021
BG0031
BG004
ID
Title
Description
OG000
MK-4166 0.0015 mg
Participant received 0.0015 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG001
MK-4166 0.0045 mg
Participant received 0.0045 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG002
MK-4166 0.014 mg
Participant received 0.014 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG003
MK-4166 0.04 mg
Participant received 0.04 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG004
MK-4166 0.12 mg
Participant received 0.12 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG005
MK-4166 0.37 mg
Participant received 0.37 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG006
MK-4166 1.1 mg
Participant received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG007
MK-4166 3.3 mg
Participant received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG008
MK-4166 10 mg
Participant received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG009
MK-4166 30 mg
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG010
MK-4166 42 mg
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG011
MK-4166 59 mg
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG012
MK-4166 82 mg
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG013
MK-4166 120 mg
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG014
MK-4166 170 mg
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG015
MK-4166 240 mg
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG016
MK-4166 340 mg
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG017
MK-4166 480 mg
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG018
MK-4166 670 mg
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG019
MK-4166 900 mg
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG020
MK-4166 1.1 mg + Pembro
Participants received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG021
MK-4166 3.3 mg + Pembro
Participants received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG022
MK-4166 10 mg + Pembro
Participants received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG023
MK-4166 30 mg + Pembro
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG024
MK-4166 42 mg + Pembro
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG025
MK-4166 59 mg + Pembro
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG026
MK-4166 82 mg + Pembro
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG027
MK-4166 120 mg + Pembro
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG028
MK-4166 170 mg + Pembro
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG029
MK-4166 240 mg + Pembro
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG030
MK-4166 340 mg + Pembro
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG031
MK-4166 480 mg + Pembro
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG032
MK-4166 670 mg + Pembro
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG033
MK-4166 900 mg + Pembro
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0031
OG0041
OG0051
OG0061
OG0071
OG0081
OG0096
OG0103
OG0113
OG0123
OG0133
OG0143
OG0155
OG0164
OG0173
OG0183
OG0193
OG0203
OG0214
OG0223
OG0233
OG0243
OG0253
OG0264
OG0273
OG0283
OG0293
OG0303
OG0313
OG0324
OG03323
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0091
OG0100
OG0110
OG0120
OG0130
OG0140
OG0150
OG0160
OG0170
OG0180
OG0190
OG0200
OG0210
OG0220
OG0230
OG0240
OG0250
OG0260
OG0270
OG0280
OG0290
OG0300
OG0310
OG0320
OG0330
Primary
Number of Participants Experiencing Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE.
Per protocol, the number of participants experiencing an AE was assessed and reported by arm (MK-4166 monotherapy and MK-4166 plus pembrolizumab combination therapy) as well as by dose cohort.
All allocated participants who received at least 1 dose of study treatment.
Posted
Count of Participants
Participants
From first dose up to 90 days post last dose (up to 27 months)
ID
Title
Description
OG000
MK-4166 Monotherapy
Participants received assigned dose of MK-4166 IV on Day 1 of each 21-day cycle, for up to 4 cycles.
OG001
MK-4166 + Pembro Combination Therapy
Participants received assigned dose of MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG002
MK-4166 0.0015 mg
Participant received 0.0015 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG003
MK-4166 0.0045 mg
Participant received 0.0045 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG004
MK-4166 0.014 mg
Participant received 0.014 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG005
MK-4166 0.04 mg
Participant received 0.04 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG006
MK-4166 0.12 mg
Participant received 0.12 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG007
MK-4166 0.37 mg
Participant received 0.37 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG008
MK-4166 1.1 mg
Participant received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG009
MK-4166 3.3 mg
Participant received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG010
MK-4166 10 mg
Participant received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG011
MK-4166 30 mg
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG012
MK-4166 42 mg
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG013
MK-4166 59 mg
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG014
MK-4166 82 mg
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG015
MK-4166 120 mg
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG016
MK-4166 170 mg
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG017
MK-4166 240 mg
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG018
MK-4166 340 mg
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG019
MK-4166 480 mg
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG020
MK-4166 670 mg
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG021
MK-4166 900 mg
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG022
MK-4166 1.1 mg + Pembro
Participants received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG023
MK-4166 3.3 mg + Pembro
Participants received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG024
MK-4166 10 mg + Pembro
Participants received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG025
MK-4166 30 mg + Pembro
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG026
MK-4166 42 mg + Pembro
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG027
MK-4166 59 mg + Pembro
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG028
MK-4166 82 mg + Pembro
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG029
MK-4166 120 mg + Pembro
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG030
MK-4166 170 mg + Pembro
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG031
MK-4166 240 mg + Pembro
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG032
MK-4166 340 mg + Pembro
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG033
MK-4166 480 mg + Pembro
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG034
MK-4166 670 mg + Pembro
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG035
MK-4166 900 mg + Pembro
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
Units
Counts
Participants
OG00048
OG00165
OG0021
OG003
Title
Denominators
Categories
Title
Measurements
OG00044
OG00163
OG0020
OG003
Primary
Number of Participants Discontinuing Study Treatment Due to AEs
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE.
Per protocol, the number of participants discontinuing study treatment due to AEs was assessed and reported by arm (MK-4166 monotherapy and MK-4166 plus pembrolizumab combination therapy) as well as by dose cohort.
All allocated participants who received at least 1 dose of study treatment.
Posted
Count of Participants
Participants
Up to approximately 24 months
ID
Title
Description
OG000
MK-4166 Monotherapy
Participants received assigned dose of MK-4166 IV on Day 1 of each 21-day cycle, for up to 4 cycles.
OG001
MK-4166 + Pembro Combination Therapy
Participants received assigned dose of MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG002
MK-4166 0.0015 mg
Participant received 0.0015 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG003
MK-4166 0.0045 mg
Participant received 0.0045 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG004
MK-4166 0.014 mg
Participant received 0.014 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG005
MK-4166 0.04 mg
Participant received 0.04 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG006
MK-4166 0.12 mg
Participant received 0.12 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG007
MK-4166 0.37 mg
Participant received 0.37 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG008
MK-4166 1.1 mg
Participant received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG009
MK-4166 3.3 mg
Participant received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG010
MK-4166 10 mg
Participant received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG011
MK-4166 30 mg
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG012
MK-4166 42 mg
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG013
MK-4166 59 mg
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG014
MK-4166 82 mg
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG015
MK-4166 120 mg
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG016
MK-4166 170 mg
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG017
MK-4166 240 mg
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG018
MK-4166 340 mg
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG019
MK-4166 480 mg
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG020
MK-4166 670 mg
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG021
MK-4166 900 mg
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG022
MK-4166 1.1 mg + Pembro
Participants received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG023
MK-4166 3.3 mg + Pembro
Participants received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG024
MK-4166 10 mg + Pembro
Participants received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG025
MK-4166 30 mg + Pembro
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG026
MK-4166 42 mg + Pembro
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG027
MK-4166 59 mg + Pembro
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG028
MK-4166 82 mg + Pembro
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG029
MK-4166 120 mg + Pembro
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG030
MK-4166 170 mg + Pembro
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG031
MK-4166 240 mg + Pembro
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG032
MK-4166 340 mg + Pembro
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG033
MK-4166 480 mg + Pembro
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG034
MK-4166 670 mg + Pembro
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG035
MK-4166 900 mg + Pembro
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
Units
Counts
Participants
OG00048
OG00165
OG0021
OG003
Title
Denominators
Categories
Title
Measurements
OG0002
OG0018
OG0020
OG003
Secondary
Maximum Concentration (Cmax) of MK-4166 Over Time
Blood samples were collected at pre-specified time points during Cycles 1-4 and plasma isolated for analysis of MK-4166 Cmax. Cmax was defined as the maximum concentration of MK-4166 reached. MK-4166 Cmax was reported by dose cohort. Per protocol, percent geometric coefficient of variation (%GCV) values were not reported for cohorts with n<2 participants.
All allocated participants who received at least 1 dose of MK-4166 and had evaluable Cmax samples. Per protocol, %GCV values were not reported for cohorts with n<2 participants. Participants with samples that were hemolyzed or analyzed outside of stability were excluded from the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Cycles 1-4: Day 1 pre-dose, at end of MK-4166 infusion (up to 10 minutes), 2 hours; Days 2, 3, 5 (Cohorts 1-9 only), 8, 15. Each cycle was 21 days. (Up to ~3 months)
ID
Title
Description
OG000
MK-4166 0.0015 mg
Participant received 0.0015 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG001
MK-4166 0.0045 mg
Participant received 0.0045 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG002
MK-4166 0.014 mg
Participant received 0.014 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG003
MK-4166 0.04 mg
Participant received 0.04 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG004
MK-4166 0.12 mg
Participant received 0.12 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG005
MK-4166 0.37 mg
Participant received 0.37 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG006
MK-4166 1.1 mg
Participant received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG007
MK-4166 3.3 mg
Participant received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG008
MK-4166 10 mg
Participant received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG009
MK-4166 30 mg
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG010
MK-4166 42 mg
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG011
MK-4166 59 mg
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG012
MK-4166 82 mg
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG013
MK-4166 120 mg
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG014
MK-4166 170 mg
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG015
MK-4166 240 mg
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG016
MK-4166 340 mg
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG017
MK-4166 480 mg
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG018
MK-4166 670 mg
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG019
MK-4166 900 mg
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG020
MK-4166 1.1 mg + Pembro
Participants received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG021
MK-4166 3.3 mg + Pembro
Participants received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG022
MK-4166 10 mg + Pembro
Participants received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG023
MK-4166 30 mg + Pembro
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG024
MK-4166 42 mg + Pembro
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG025
MK-4166 59 mg + Pembro
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG026
MK-4166 82 mg + Pembro
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG027
MK-4166 120 mg + Pembro
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG028
MK-4166 170 mg + Pembro
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG029
MK-4166 240 mg + Pembro
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG030
MK-4166 340 mg + Pembro
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG031
MK-4166 480 mg + Pembro
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG032
MK-4166 670 mg + Pembro
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG033
MK-4166 900 mg + Pembro
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG003
Title
Denominators
Categories
Cycle 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG003
Secondary
Time to Maximum Concentration (Tmax) of MK-4166 Over Time
Blood samples were collected at pre-specified time points during Cycles 1-4 and plasma isolated for analysis of MK-4166 Tmax. Tmax was defined as time to the maximum concentration of MK-4166 reached. MK-4166 Tmax was reported by dose cohort.
All allocated participants who received at least 1 dose of MK-4166 and had evaluable Tmax samples. Participants with samples that were hemolyzed or analyzed outside of stability were excluded from the analysis.
Posted
Median
Full Range
Days
Cycles 1-4: Day 1 pre-dose, at end of MK-4166 infusion (up to 10 minutes), 2 hours; Days 2, 3, 5 (Cohorts 1-9 only), 8, 15. Each cycle was 21 days. (Up to ~3 months)
ID
Title
Description
OG000
MK-4166 0.0015 mg
Participant received 0.0015 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG001
MK-4166 0.0045 mg
Participant received 0.0045 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG002
MK-4166 0.014 mg
Participant received 0.014 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG003
MK-4166 0.04 mg
Participant received 0.04 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG004
MK-4166 0.12 mg
Participant received 0.12 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG005
MK-4166 0.37 mg
Participant received 0.37 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG006
MK-4166 1.1 mg
Participant received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG007
MK-4166 3.3 mg
Participant received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG008
MK-4166 10 mg
Participant received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG009
MK-4166 30 mg
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG010
MK-4166 42 mg
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG011
MK-4166 59 mg
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG012
MK-4166 82 mg
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG013
MK-4166 120 mg
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG014
MK-4166 170 mg
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG015
MK-4166 240 mg
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG016
MK-4166 340 mg
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG017
MK-4166 480 mg
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG018
MK-4166 670 mg
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG019
MK-4166 900 mg
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG020
MK-4166 1.1 mg + Pembro
Participants received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG021
MK-4166 3.3 mg + Pembro
Participants received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG022
MK-4166 10 mg + Pembro
Participants received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG023
MK-4166 30 mg + Pembro
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG024
MK-4166 42 mg + Pembro
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG025
MK-4166 59 mg + Pembro
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG026
MK-4166 82 mg + Pembro
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG027
MK-4166 120 mg + Pembro
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG028
MK-4166 170 mg + Pembro
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG029
MK-4166 240 mg + Pembro
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG030
MK-4166 340 mg + Pembro
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG031
MK-4166 480 mg + Pembro
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG032
MK-4166 670 mg + Pembro
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG033
MK-4166 900 mg + Pembro
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG003
Title
Denominators
Categories
Cycle 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG003
Secondary
Terminal Half-Life (t ½) of MK-4166 Over Time
Blood samples were collected at pre-specified time points during Cycles 1-4 and plasma isolated for analysis of MK-4166 t½. t½ was defined as the time required to divide the MK-4166 plasma concentration by two after reaching pseudo-equilibrium, following a single dose of MK-4166. MK-4166 t½ was reported by dose cohort. Per protocol, % GCV values were not reported for cohorts with n<2 participants.
All allocated participants who received at least 1 dose of MK-4166 and had evaluable t½ samples. Per protocol, %GCV values were not reported for cohorts with n<2 participants. Participants with samples that were hemolyzed or analyzed outside of stability were excluded from the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
Days
Cycles 1-4: Day 1 pre-dose, at end of MK-4166 infusion (up to 10 minutes), 2 hours; Days 2, 3, 5 (Cohorts 1-9 only), 8, 15. Each cycle was 21 days. (Up to ~3 months)
ID
Title
Description
OG000
MK-4166 0.0015 mg
Participant received 0.0015 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG001
MK-4166 0.0045 mg
Participant received 0.0045 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG002
MK-4166 0.014 mg
Participant received 0.014 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG003
MK-4166 0.04 mg
Participant received 0.04 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG004
MK-4166 0.12 mg
Participant received 0.12 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG005
MK-4166 0.37 mg
Participant received 0.37 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG006
MK-4166 1.1 mg
Participant received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG007
MK-4166 3.3 mg
Participant received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG008
MK-4166 10 mg
Participant received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG009
MK-4166 30 mg
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG010
MK-4166 42 mg
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG011
MK-4166 59 mg
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG012
MK-4166 82 mg
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG013
MK-4166 120 mg
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG014
MK-4166 170 mg
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG015
MK-4166 240 mg
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG016
MK-4166 340 mg
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG017
MK-4166 480 mg
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG018
MK-4166 670 mg
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG019
MK-4166 900 mg
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG020
MK-4166 1.1 mg + Pembro
Participants received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG021
MK-4166 3.3 mg + Pembro
Participants received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG022
MK-4166 10 mg + Pembro
Participants received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG023
MK-4166 30 mg + Pembro
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG024
MK-4166 42 mg + Pembro
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG025
MK-4166 59 mg + Pembro
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG026
MK-4166 82 mg + Pembro
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG027
MK-4166 120 mg + Pembro
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG028
MK-4166 170 mg + Pembro
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG029
MK-4166 240 mg + Pembro
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG030
MK-4166 340 mg + Pembro
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG031
MK-4166 480 mg + Pembro
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG032
MK-4166 670 mg + Pembro
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG033
MK-4166 900 mg + Pembro
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG003
Title
Denominators
Categories
Cycle 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG003
Secondary
Area Under the Concentration-Time Curve of MK-4166 From Time Zero to 21 Hours After Dosing (AUC 0-21) Over Time
Blood samples were collected at pre-specified time points during Cycles 1-4 and plasma isolated for analysis of MK-4166 AUC0-21. AUC0-21 was defined as the area under the concentration-time curve of MK-4166 from time zero to 21 hours after dosing. MK-4166 AUC0-21 was reported by dose cohort. Per protocol, % GCV values were not reported for cohorts with n<2 participants.
All allocated participants who received at least 1 dose of MK-4166 and had evaluable AUC0-21 samples. Per protocol, %GCV values were not reported for cohorts with n<2 participants. Participants with samples that were hemolyzed or analyzed outside of stability were excluded from the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
Days•ng/mL
Cycles 1-4: Day 1 pre-dose, at end of MK-4166 infusion (up to 10 minutes), 2 hours; Day 2. Each cycle was 21 days. (Up to ~3 months)
ID
Title
Description
OG000
MK-4166 0.0015 mg
Participant received 0.0015 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG001
MK-4166 0.0045 mg
Participant received 0.0045 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG002
MK-4166 0.014 mg
Participant received 0.014 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG003
MK-4166 0.04 mg
Participant received 0.04 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG004
MK-4166 0.12 mg
Participant received 0.12 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG005
MK-4166 0.37 mg
Participant received 0.37 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG006
MK-4166 1.1 mg
Participant received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG007
MK-4166 3.3 mg
Participant received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG008
MK-4166 10 mg
Participant received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG009
MK-4166 30 mg
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG010
MK-4166 42 mg
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG011
MK-4166 59 mg
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG012
MK-4166 82 mg
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG013
MK-4166 120 mg
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG014
MK-4166 170 mg
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG015
MK-4166 240 mg
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG016
MK-4166 340 mg
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG017
MK-4166 480 mg
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG018
MK-4166 670 mg
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG019
MK-4166 900 mg
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG020
MK-4166 1.1 mg + Pembro
Participants received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG021
MK-4166 3.3 mg + Pembro
Participants received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG022
MK-4166 10 mg + Pembro
Participants received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG023
MK-4166 30 mg + Pembro
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG024
MK-4166 42 mg + Pembro
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG025
MK-4166 59 mg + Pembro
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG026
MK-4166 82 mg + Pembro
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG027
MK-4166 120 mg + Pembro
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG028
MK-4166 170 mg + Pembro
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG029
MK-4166 240 mg + Pembro
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG030
MK-4166 340 mg + Pembro
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG031
MK-4166 480 mg + Pembro
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG032
MK-4166 670 mg + Pembro
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG033
MK-4166 900 mg + Pembro
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG003
Title
Denominators
Categories
Cycle 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG003
Secondary
Area Under the Concentration-Time Curve of MK-4166 From Time Zero to The Last Quantifiable Sample (AUC 0-last) Over Time
Blood samples were collected at pre-specified time points during Cycles 1-4 and plasma isolated for analysis of MK-4166 AUC0-last. AUC0-last was defined as the area under the concentration-time curve of MK-4166 from time zero to the last quantifiable sample. MK-4166 AUC0-last was reported by dose cohort. Per protocol, % GCV values were not reported for cohorts with n<2 participants.
All allocated participants who received at least 1 dose of MK-4166 and had evaluable AUC0-last samples. Per protocol, %GCV values were not reported for cohorts with n<2 participants. Participants with samples that were hemolyzed or analyzed outside of stability were excluded from the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
Days•ng/mL
Cycles 1-4: Day 1 pre-dose, at end of MK-4166 infusion (up to 10 minutes), 2 hours; Days 2, 3, 5 (Cohorts 1-9 only), 8, 15. Each cycle was 21 days. (Up to ~3 months)
ID
Title
Description
OG000
MK-4166 0.0015 mg
Participant received 0.0015 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG001
MK-4166 0.0045 mg
Participant received 0.0045 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG002
MK-4166 0.014 mg
Participant received 0.014 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG003
MK-4166 0.04 mg
Participant received 0.04 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG004
MK-4166 0.12 mg
Participant received 0.12 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG005
MK-4166 0.37 mg
Participant received 0.37 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG006
MK-4166 1.1 mg
Participant received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG007
MK-4166 3.3 mg
Participant received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG008
MK-4166 10 mg
Participant received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG009
MK-4166 30 mg
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG010
MK-4166 42 mg
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG011
MK-4166 59 mg
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG012
MK-4166 82 mg
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG013
MK-4166 120 mg
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG014
MK-4166 170 mg
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG015
MK-4166 240 mg
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG016
MK-4166 340 mg
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG017
MK-4166 480 mg
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG018
MK-4166 670 mg
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG019
MK-4166 900 mg
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG020
MK-4166 1.1 mg + Pembro
Participants received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG021
MK-4166 3.3 mg + Pembro
Participants received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG022
MK-4166 10 mg + Pembro
Participants received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG023
MK-4166 30 mg + Pembro
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG024
MK-4166 42 mg + Pembro
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG025
MK-4166 59 mg + Pembro
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG026
MK-4166 82 mg + Pembro
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG027
MK-4166 120 mg + Pembro
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG028
MK-4166 170 mg + Pembro
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG029
MK-4166 240 mg + Pembro
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG030
MK-4166 340 mg + Pembro
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG031
MK-4166 480 mg + Pembro
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG032
MK-4166 670 mg + Pembro
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG033
MK-4166 900 mg + Pembro
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG003
Title
Denominators
Categories
Cycle 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG003
Secondary
Area Under the Concentration-Time Curve of MK-4166 From Time Zero to Infinity (AUC 0-inf) Over Time
Blood samples were collected at pre-specified time points during Cycles 1-4 and plasma isolated for analysis of MK-4166 AUC0-inf. AUC0-inf was defined as the area under the concentration-time curve of MK-4166 from time zero to infinity. MK-4166 AUC0-inf was reported by dose cohort. Per protocol, % GCV values were not reported for cohorts with n<2 participants.
All allocated participants who received at least 1 dose of MK-4166 and had evaluable AUC0-inf samples. Per protocol, %GCV values were not reported for cohorts with n<2 participants. Participants with samples that were hemolyzed or analyzed outside of stability were excluded from the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
Days•ng/mL
Cycles 1-4: Day 1 pre-dose, at end of MK-4166 infusion (up to 10 minutes), 2 hours; Days 2, 3, 5 (Cohorts 1-9 only), 8, 15. Each cycle was 21 days. (Up to ~3 months)
ID
Title
Description
OG000
MK-4166 0.0015 mg
Participant received 0.0015 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG001
MK-4166 0.0045 mg
Participant received 0.0045 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG002
MK-4166 0.014 mg
Participant received 0.014 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG003
MK-4166 0.04 mg
Participant received 0.04 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG004
MK-4166 0.12 mg
Participant received 0.12 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG005
MK-4166 0.37 mg
Participant received 0.37 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG006
MK-4166 1.1 mg
Participant received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG007
MK-4166 3.3 mg
Participant received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG008
MK-4166 10 mg
Participant received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG009
MK-4166 30 mg
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG010
MK-4166 42 mg
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG011
MK-4166 59 mg
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG012
MK-4166 82 mg
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG013
MK-4166 120 mg
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG014
MK-4166 170 mg
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG015
MK-4166 240 mg
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG016
MK-4166 340 mg
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG017
MK-4166 480 mg
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG018
MK-4166 670 mg
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG019
MK-4166 900 mg
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG020
MK-4166 1.1 mg + Pembro
Participants received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG021
MK-4166 3.3 mg + Pembro
Participants received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG022
MK-4166 10 mg + Pembro
Participants received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG023
MK-4166 30 mg + Pembro
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG024
MK-4166 42 mg + Pembro
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG025
MK-4166 59 mg + Pembro
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG026
MK-4166 82 mg + Pembro
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG027
MK-4166 120 mg + Pembro
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG028
MK-4166 170 mg + Pembro
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG029
MK-4166 240 mg + Pembro
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG030
MK-4166 340 mg + Pembro
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG031
MK-4166 480 mg + Pembro
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG032
MK-4166 670 mg + Pembro
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG033
MK-4166 900 mg + Pembro
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG003
Title
Denominators
Categories
Cycle 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG003
Secondary
Apparent Clearance (CL) of MK-4166 Over Time
Blood samples were collected at pre-specified time points during Cycles 1-4 and plasma isolated for analysis of MK-4166 CL. CL was defined as the volume of plasma from which MK-4166 is eliminated per unit time following IV MK-4166 administration. MK-4166 CL was reported by dose cohort. Per protocol, % GCV values were not reported for cohorts with n<2 participants.
All allocated participants who received at least 1 dose of MK-4166 and had evaluable CL samples. Per protocol, %GCV values were not reported for cohorts with n<2 participants. Participants with samples that were hemolyzed or analyzed outside of stability were excluded from the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liters (L)/day
Cycles 1-4: Day 1 pre-dose, at end of MK-4166 infusion (up to 10 minutes), 2 hours; Days 2, 3, 5 (Cohorts 1-9 only), 8, 15. Each cycle was 21 days. (Up to ~3 months)
ID
Title
Description
OG000
MK-4166 0.0015 mg
Participant received 0.0015 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG001
MK-4166 0.0045 mg
Participant received 0.0045 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG002
MK-4166 0.014 mg
Participant received 0.014 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG003
MK-4166 0.04 mg
Participant received 0.04 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG004
MK-4166 0.12 mg
Participant received 0.12 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG005
MK-4166 0.37 mg
Participant received 0.37 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG006
MK-4166 1.1 mg
Participant received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG007
MK-4166 3.3 mg
Participant received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG008
MK-4166 10 mg
Participant received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG009
MK-4166 30 mg
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG010
MK-4166 42 mg
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG011
MK-4166 59 mg
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG012
MK-4166 82 mg
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG013
MK-4166 120 mg
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG014
MK-4166 170 mg
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG015
MK-4166 240 mg
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG016
MK-4166 340 mg
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG017
MK-4166 480 mg
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG018
MK-4166 670 mg
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG019
MK-4166 900 mg
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG020
MK-4166 1.1 mg + Pembro
Participants received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG021
MK-4166 3.3 mg + Pembro
Participants received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG022
MK-4166 10 mg + Pembro
Participants received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG023
MK-4166 30 mg + Pembro
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG024
MK-4166 42 mg + Pembro
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG025
MK-4166 59 mg + Pembro
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG026
MK-4166 82 mg + Pembro
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG027
MK-4166 120 mg + Pembro
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG028
MK-4166 170 mg + Pembro
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG029
MK-4166 240 mg + Pembro
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG030
MK-4166 340 mg + Pembro
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG031
MK-4166 480 mg + Pembro
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG032
MK-4166 670 mg + Pembro
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG033
MK-4166 900 mg + Pembro
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG003
Title
Denominators
Categories
Cycle 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG003
Secondary
Apparent Volume of Distribution (V) of MK-4166 Over Time
Blood samples were collected at pre-specified time points during Cycles 1-4 and plasma isolated for analysis of MK-4166 V. V was defined as the theoretical volume that would be necessary to contain the total amount of administered MK-4166 at the same concentration that it is observed in the blood plasma. MK-4166 V was reported by dose cohort. Per protocol, % GCV values were not reported for cohorts with n<2 participants.
All allocated participants who received at least 1 dose of MK-4166 and had evaluable V samples. Per protocol, %GCV values were not reported for cohorts with n<2 participants. Participants with samples that were hemolyzed or analyzed outside of stability were excluded from the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liters
Cycles 1-4: Day 1 pre-dose, at end of MK-4166 infusion (up to 10 minutes), 2 hours; Days 2, 3, 5 (Cohorts 1-9 only), 8, 15. Each cycle was 21 days. (Up to ~3 months)
ID
Title
Description
OG000
MK-4166 0.0015 mg
Participant received 0.0015 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG001
MK-4166 0.0045 mg
Participant received 0.0045 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG002
MK-4166 0.014 mg
Participant received 0.014 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG003
MK-4166 0.04 mg
Participant received 0.04 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG004
MK-4166 0.12 mg
Participant received 0.12 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG005
MK-4166 0.37 mg
Participant received 0.37 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG006
MK-4166 1.1 mg
Participant received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG007
MK-4166 3.3 mg
Participant received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG008
MK-4166 10 mg
Participant received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG009
MK-4166 30 mg
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG010
MK-4166 42 mg
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG011
MK-4166 59 mg
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG012
MK-4166 82 mg
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG013
MK-4166 120 mg
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG014
MK-4166 170 mg
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG015
MK-4166 240 mg
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG016
MK-4166 340 mg
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG017
MK-4166 480 mg
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG018
MK-4166 670 mg
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG019
MK-4166 900 mg
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG020
MK-4166 1.1 mg + Pembro
Participants received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG021
MK-4166 3.3 mg + Pembro
Participants received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG022
MK-4166 10 mg + Pembro
Participants received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG023
MK-4166 30 mg + Pembro
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG024
MK-4166 42 mg + Pembro
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG025
MK-4166 59 mg + Pembro
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG026
MK-4166 82 mg + Pembro
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG027
MK-4166 120 mg + Pembro
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG028
MK-4166 170 mg + Pembro
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG029
MK-4166 240 mg + Pembro
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG030
MK-4166 340 mg + Pembro
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG031
MK-4166 480 mg + Pembro
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG032
MK-4166 670 mg + Pembro
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG033
MK-4166 900 mg + Pembro
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG003
Title
Denominators
Categories
Cycle 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG003
Secondary
Maximum Concentration (Cmax) of Pembrolizumab Over Time
Blood samples were collected at pre-specified time points during Cycles 1-4 from MK-4166 plus pembrolizumab combination cohorts only and plasma isolated for analysis of pembrolizumab Cmax. Cmax was defined as the maximum concentration of pembrolizumab reached. Pembrolizumab Cmax was reported by dose cohort for all participants that received MK-4166 plus pembrolizumab combination therapy. Per protocol, participants receiving MK-4166 monotherapy were excluded from this analysis.
All allocated participants who received ≥1 dose of pembrolizumab and had evaluable Cmax samples. Per protocol, %GCV values were not reported for cohorts with n<2 participants, and MK-4166 monotherapy dose cohorts were not analyzed. Participants with samples that were hemolyzed or analyzed outside of stability were excluded from the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Cycles 1-4: Day 1 pre-dose, at end of pembro infusion (up to 10 minutes), at end of MK-4166 infusion (up to 10 minutes), ~2 hours after start of MK-4166 infusion, Days 2, 3, 8, 15. Each cycle was 21 days. (Up to ~3 months)
ID
Title
Description
OG000
MK-4166 0.0015 mg
Participant received 0.0015 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG001
MK-4166 0.0045 mg
Participant received 0.0045 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG002
MK-4166 0.014 mg
Participant received 0.014 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG003
MK-4166 0.04 mg
Participant received 0.04 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG004
MK-4166 0.12 mg
Participant received 0.12 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG005
MK-4166 0.37 mg
Participant received 0.37 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG006
MK-4166 1.1 mg
Participant received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG007
MK-4166 3.3 mg
Participant received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG008
MK-4166 10 mg
Participant received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG009
MK-4166 30 mg
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG010
MK-4166 42 mg
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG011
MK-4166 59 mg
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG012
MK-4166 82 mg
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG013
MK-4166 120 mg
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG014
MK-4166 170 mg
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG015
MK-4166 240 mg
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG016
MK-4166 340 mg
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG017
MK-4166 480 mg
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG018
MK-4166 670 mg
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG019
MK-4166 900 mg
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG020
MK-4166 1.1 mg + Pembro
Participants received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG021
MK-4166 3.3 mg + Pembro
Participants received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG022
MK-4166 10 mg + Pembro
Participants received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG023
MK-4166 30 mg + Pembro
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG024
MK-4166 42 mg + Pembro
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG025
MK-4166 59 mg + Pembro
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG026
MK-4166 82 mg + Pembro
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG027
MK-4166 120 mg + Pembro
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG028
MK-4166 170 mg + Pembro
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG029
MK-4166 240 mg + Pembro
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG030
MK-4166 340 mg + Pembro
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG031
MK-4166 480 mg + Pembro
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG032
MK-4166 670 mg + Pembro
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG033
MK-4166 900 mg + Pembro
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Title
Denominators
Categories
Cycle 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Secondary
Time to Maximum Concentration (Tmax) of Pembrolizumab Over Time
Blood samples were collected at pre-specified time points during Cycles 1-4 from MK-4166 plus pembrolizumab combination cohorts only and plasma isolated for analysis of pembrolizumab Tmax. Tmax was defined as time to the maximum concentration of pembrolizumab reached. Pembrolizumab Tmax was reported by dose cohort for all participants that received MK-4166 plus pembrolizumab combination therapy. Per protocol, participants receiving MK-4166 monotherapy were excluded from this analysis.
All allocated participants who received ≥1 dose of pembrolizumab and had evaluable Tmax samples. Per protocol, MK-4166 monotherapy dose cohorts were not analyzed. Participants with samples that were hemolyzed or analyzed outside of stability were excluded from the analysis.
Posted
Median
Full Range
Days
Cycles 1-4: Day 1 pre-dose, at end of pembro infusion (up to 10 minutes), at end of MK-4166 infusion (up to 10 minutes), ~2 hours after start of MK-4166 infusion, Days 2, 3, 8, 15. Each cycle was 21 days. (Up to ~3 months)
ID
Title
Description
OG000
MK-4166 0.0015 mg
Participant received 0.0015 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG001
MK-4166 0.0045 mg
Participant received 0.0045 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG002
MK-4166 0.014 mg
Participant received 0.014 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG003
MK-4166 0.04 mg
Participant received 0.04 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG004
MK-4166 0.12 mg
Participant received 0.12 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG005
MK-4166 0.37 mg
Participant received 0.37 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG006
MK-4166 1.1 mg
Participant received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG007
MK-4166 3.3 mg
Participant received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG008
MK-4166 10 mg
Participant received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG009
MK-4166 30 mg
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG010
MK-4166 42 mg
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG011
MK-4166 59 mg
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG012
MK-4166 82 mg
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG013
MK-4166 120 mg
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG014
MK-4166 170 mg
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG015
MK-4166 240 mg
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG016
MK-4166 340 mg
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG017
MK-4166 480 mg
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG018
MK-4166 670 mg
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG019
MK-4166 900 mg
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG020
MK-4166 1.1 mg + Pembro
Participants received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG021
MK-4166 3.3 mg + Pembro
Participants received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG022
MK-4166 10 mg + Pembro
Participants received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG023
MK-4166 30 mg + Pembro
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG024
MK-4166 42 mg + Pembro
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG025
MK-4166 59 mg + Pembro
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG026
MK-4166 82 mg + Pembro
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG027
MK-4166 120 mg + Pembro
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG028
MK-4166 170 mg + Pembro
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG029
MK-4166 240 mg + Pembro
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG030
MK-4166 340 mg + Pembro
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG031
MK-4166 480 mg + Pembro
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG032
MK-4166 670 mg + Pembro
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG033
MK-4166 900 mg + Pembro
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Title
Denominators
Categories
Cycle 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Secondary
Terminal Half-Life (t ½) of Pembrolizumab Over Time
Blood samples were collected at pre-specified time points during Cycles 1-4 from MK-4166 plus pembrolizumab combination cohorts only and plasma isolated for analysis of pembrolizumab t½. t½ was defined as the time required to divide the pembrolizumab plasma concentration by two after reaching pseudo-equilibrium, following a single dose of pembrolizumab. Pembrolizumab t½ was reported by dose cohort for all participants that received MK-4166 plus pembrolizumab combination therapy. Per protocol, participants receiving MK-4166 monotherapy were excluded from this analysis.
All allocated participants who received ≥1 dose of pembrolizumab and had evaluable t½ samples. Per protocol, %GCV values were not reported for cohorts with n<2 participants, and MK-4166 monotherapy dose cohorts were not analyzed. Participants with samples that were hemolyzed or analyzed outside of stability were excluded from the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
Days
Cycles 1-4: Day 1 pre-dose, at end of pembro infusion (up to 10 minutes), at end of MK-4166 infusion (up to 10 minutes), ~2 hours after start of MK-4166 infusion, Days 2, 3, 8, 15. Each cycle was 21 days. (Up to ~3 months)
ID
Title
Description
OG000
MK-4166 0.0015 mg
Participant received 0.0015 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG001
MK-4166 0.0045 mg
Participant received 0.0045 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG002
MK-4166 0.014 mg
Participant received 0.014 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG003
MK-4166 0.04 mg
Participant received 0.04 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG004
MK-4166 0.12 mg
Participant received 0.12 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG005
MK-4166 0.37 mg
Participant received 0.37 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG006
MK-4166 1.1 mg
Participant received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG007
MK-4166 3.3 mg
Participant received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG008
MK-4166 10 mg
Participant received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG009
MK-4166 30 mg
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG010
MK-4166 42 mg
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG011
MK-4166 59 mg
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG012
MK-4166 82 mg
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG013
MK-4166 120 mg
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG014
MK-4166 170 mg
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG015
MK-4166 240 mg
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG016
MK-4166 340 mg
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG017
MK-4166 480 mg
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG018
MK-4166 670 mg
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG019
MK-4166 900 mg
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG020
MK-4166 1.1 mg + Pembro
Participants received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG021
MK-4166 3.3 mg + Pembro
Participants received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG022
MK-4166 10 mg + Pembro
Participants received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG023
MK-4166 30 mg + Pembro
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG024
MK-4166 42 mg + Pembro
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG025
MK-4166 59 mg + Pembro
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG026
MK-4166 82 mg + Pembro
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG027
MK-4166 120 mg + Pembro
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG028
MK-4166 170 mg + Pembro
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG029
MK-4166 240 mg + Pembro
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG030
MK-4166 340 mg + Pembro
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG031
MK-4166 480 mg + Pembro
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG032
MK-4166 670 mg + Pembro
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG033
MK-4166 900 mg + Pembro
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Title
Denominators
Categories
Cycle 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Secondary
Area Under the Concentration-Time Curve of Pembrolizumab From Time Zero to 21 Hours After Dosing (AUC 0-21) Over Time
Blood samples were collected at pre-specified time points during Cycles 1-4 from MK-4166 plus pembrolizumab combination cohorts only and plasma isolated for analysis of pembrolizumab AUC0-21. AUC0-21 was defined as the area under the concentration-time curve of pembrolizumab from time zero to 21 hours after dosing. Pembrolizumab AUC0-21 was reported by dose cohort for all participants that received MK-4166 plus pembrolizumab combination therapy. Per protocol, participants receiving MK-4166 monotherapy were excluded from this analysis.
All allocated participants who received ≥1 dose of pembrolizumab and had evaluable AUC0-21 samples. Per protocol, %GCV values were not reported for cohorts with n<2 participants, and MK-4166 monotherapy dose cohorts were not analyzed. Participants with samples that were hemolyzed or analyzed outside of stability were excluded from the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
Days•ng/mL
Cycles 1-4: Day 1 pre-dose, at end of pembro infusion (up to 10 minutes), at end of MK-4166 infusion (up to 10 minutes), ~2 hours after start of MK-4166 infusion, Day 2. Each cycle was 21 days. (Up to ~3 months)
ID
Title
Description
OG000
MK-4166 0.0015 mg
Participant received 0.0015 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG001
MK-4166 0.0045 mg
Participant received 0.0045 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG002
MK-4166 0.014 mg
Participant received 0.014 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG003
MK-4166 0.04 mg
Participant received 0.04 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG004
MK-4166 0.12 mg
Participant received 0.12 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG005
MK-4166 0.37 mg
Participant received 0.37 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG006
MK-4166 1.1 mg
Participant received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG007
MK-4166 3.3 mg
Participant received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG008
MK-4166 10 mg
Participant received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG009
MK-4166 30 mg
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG010
MK-4166 42 mg
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG011
MK-4166 59 mg
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG012
MK-4166 82 mg
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG013
MK-4166 120 mg
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG014
MK-4166 170 mg
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG015
MK-4166 240 mg
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG016
MK-4166 340 mg
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG017
MK-4166 480 mg
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG018
MK-4166 670 mg
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG019
MK-4166 900 mg
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG020
MK-4166 1.1 mg + Pembro
Participants received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG021
MK-4166 3.3 mg + Pembro
Participants received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG022
MK-4166 10 mg + Pembro
Participants received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG023
MK-4166 30 mg + Pembro
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG024
MK-4166 42 mg + Pembro
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG025
MK-4166 59 mg + Pembro
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG026
MK-4166 82 mg + Pembro
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG027
MK-4166 120 mg + Pembro
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG028
MK-4166 170 mg + Pembro
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG029
MK-4166 240 mg + Pembro
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG030
MK-4166 340 mg + Pembro
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG031
MK-4166 480 mg + Pembro
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG032
MK-4166 670 mg + Pembro
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG033
MK-4166 900 mg + Pembro
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Title
Denominators
Categories
Cycle 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Secondary
Area Under the Concentration-Time Curve of Pembrolizumab From Time Zero to The Last Quantifiable Sample (AUC 0-last) Over Time
Blood samples were collected at pre-specified time points during Cycles 1-4 from MK-4166 plus pembrolizumab combination cohorts only and plasma isolated for analysis of pembrolizumab AUC0-last. AUC0-last was defined as the area under the concentration-time curve of pembrolizumab from time zero to the last quantifiable sample. Pembrolizumab AUC0-last was reported by dose cohort for all participants that received MK-4166 plus pembrolizumab combination therapy. Per protocol, participants receiving MK-4166 monotherapy were excluded from this analysis.
All allocated participants who received ≥1 dose of pembrolizumab and had evaluable AUC0-last samples. Per protocol, %GCV values were not reported for cohorts with n<2 participants, and MK-4166 monotherapy dose cohorts were not analyzed. Participants with samples that were hemolyzed or analyzed outside of stability were excluded from the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
Days•ng/mL
Cycles 1-4: Day 1 pre-dose, at end of pembro infusion (up to 10 minutes), at end of MK-4166 infusion (up to 10 minutes), ~2 hours after start of MK-4166 infusion, Days 2, 3, 8, 15. Each cycle was 21 days. (Up to ~3 months)
ID
Title
Description
OG000
MK-4166 0.0015 mg
Participant received 0.0015 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG001
MK-4166 0.0045 mg
Participant received 0.0045 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG002
MK-4166 0.014 mg
Participant received 0.014 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG003
MK-4166 0.04 mg
Participant received 0.04 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG004
MK-4166 0.12 mg
Participant received 0.12 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG005
MK-4166 0.37 mg
Participant received 0.37 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG006
MK-4166 1.1 mg
Participant received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG007
MK-4166 3.3 mg
Participant received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG008
MK-4166 10 mg
Participant received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG009
MK-4166 30 mg
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG010
MK-4166 42 mg
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG011
MK-4166 59 mg
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG012
MK-4166 82 mg
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG013
MK-4166 120 mg
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG014
MK-4166 170 mg
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG015
MK-4166 240 mg
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG016
MK-4166 340 mg
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG017
MK-4166 480 mg
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG018
MK-4166 670 mg
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG019
MK-4166 900 mg
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG020
MK-4166 1.1 mg + Pembro
Participants received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG021
MK-4166 3.3 mg + Pembro
Participants received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG022
MK-4166 10 mg + Pembro
Participants received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG023
MK-4166 30 mg + Pembro
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG024
MK-4166 42 mg + Pembro
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG025
MK-4166 59 mg + Pembro
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG026
MK-4166 82 mg + Pembro
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG027
MK-4166 120 mg + Pembro
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG028
MK-4166 170 mg + Pembro
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG029
MK-4166 240 mg + Pembro
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG030
MK-4166 340 mg + Pembro
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG031
MK-4166 480 mg + Pembro
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG032
MK-4166 670 mg + Pembro
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG033
MK-4166 900 mg + Pembro
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Title
Denominators
Categories
Cycle 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Secondary
Area Under the Concentration-Time Curve of Pembrolizumab From Time Zero to Infinity (AUC 0-inf) Over Time
Blood samples were collected at pre-specified time points during Cycles 1-4 from MK-4166 plus pembrolizumab combination cohorts only and plasma isolated for analysis of pembrolizumab AUC0-inf. AUC0-inf was defined as the area under the concentration-time curve of pembrolizumab from time zero to infinity. Pembrolizumab AUC0-inf was reported by dose cohort for all participants that received MK-4166 plus pembrolizumab combination therapy. Per protocol, participants receiving MK-4166 monotherapy were excluded from this analysis.
All allocated participants who received ≥1 dose of pembrolizumab and had evaluable AUC0-inf samples. Per protocol, %GCV values were not reported for cohorts with n<2 participants, and MK-4166 monotherapy dose cohorts were not analyzed. Participants with samples that were hemolyzed or analyzed outside of stability were excluded from the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
Days•ng/mL
Cycles 1-4: Day 1 pre-dose, at end of pembro infusion (up to 10 minutes), at end of MK-4166 infusion (up to 10 minutes), ~2 hours after start of MK-4166 infusion, Days 2, 3, 8, 15. Each cycle was 21 days. (Up to ~3 months)
ID
Title
Description
OG000
MK-4166 0.0015 mg
Participant received 0.0015 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG001
MK-4166 0.0045 mg
Participant received 0.0045 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG002
MK-4166 0.014 mg
Participant received 0.014 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG003
MK-4166 0.04 mg
Participant received 0.04 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG004
MK-4166 0.12 mg
Participant received 0.12 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG005
MK-4166 0.37 mg
Participant received 0.37 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG006
MK-4166 1.1 mg
Participant received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG007
MK-4166 3.3 mg
Participant received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG008
MK-4166 10 mg
Participant received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG009
MK-4166 30 mg
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG010
MK-4166 42 mg
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG011
MK-4166 59 mg
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG012
MK-4166 82 mg
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG013
MK-4166 120 mg
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG014
MK-4166 170 mg
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG015
MK-4166 240 mg
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG016
MK-4166 340 mg
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG017
MK-4166 480 mg
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG018
MK-4166 670 mg
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG019
MK-4166 900 mg
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG020
MK-4166 1.1 mg + Pembro
Participants received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG021
MK-4166 3.3 mg + Pembro
Participants received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG022
MK-4166 10 mg + Pembro
Participants received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG023
MK-4166 30 mg + Pembro
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG024
MK-4166 42 mg + Pembro
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG025
MK-4166 59 mg + Pembro
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG026
MK-4166 82 mg + Pembro
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG027
MK-4166 120 mg + Pembro
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG028
MK-4166 170 mg + Pembro
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG029
MK-4166 240 mg + Pembro
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG030
MK-4166 340 mg + Pembro
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG031
MK-4166 480 mg + Pembro
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG032
MK-4166 670 mg + Pembro
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG033
MK-4166 900 mg + Pembro
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Title
Denominators
Categories
Cycle 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Secondary
Apparent Clearance (CL) of Pembrolizumab Over Time
Blood samples were collected at pre-specified time points during Cycles 1-4 from MK-4166 plus pembrolizumab combination cohorts only and plasma isolated for analysis of pembrolizumab CL. CL was defined as the volume of plasma from which pembrolizumab is eliminated per unit time following IV pembrolizumab administration. Pembrolizumab CL was reported by dose cohort for all participants that received MK-4166 plus pembrolizumab combination therapy. Per protocol, participants receiving MK-4166 monotherapy were excluded from this analysis.
All allocated participants who received ≥1 dose of pembrolizumab and had evaluable CL samples. Per protocol, %GCV values were not reported for cohorts with n<2 participants, and MK-4166 monotherapy dose cohorts were not analyzed. Participants with samples that were hemolyzed or analyzed outside of stability were excluded from the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
L/Day
Cycles 1-4: Day 1 pre-dose, at end of pembro infusion (up to 10 minutes), at end of MK-4166 infusion (up to 10 minutes), ~2 hours after start of MK-4166 infusion, Days 2, 3, 8, 15. Each cycle was 21 days. (Up to ~3 months)
ID
Title
Description
OG000
MK-4166 0.0015 mg
Participant received 0.0015 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG001
MK-4166 0.0045 mg
Participant received 0.0045 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG002
MK-4166 0.014 mg
Participant received 0.014 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG003
MK-4166 0.04 mg
Participant received 0.04 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG004
MK-4166 0.12 mg
Participant received 0.12 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG005
MK-4166 0.37 mg
Participant received 0.37 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG006
MK-4166 1.1 mg
Participant received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG007
MK-4166 3.3 mg
Participant received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG008
MK-4166 10 mg
Participant received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG009
MK-4166 30 mg
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG010
MK-4166 42 mg
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG011
MK-4166 59 mg
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG012
MK-4166 82 mg
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG013
MK-4166 120 mg
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG014
MK-4166 170 mg
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG015
MK-4166 240 mg
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG016
MK-4166 340 mg
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG017
MK-4166 480 mg
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG018
MK-4166 670 mg
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG019
MK-4166 900 mg
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG020
MK-4166 1.1 mg + Pembro
Participants received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG021
MK-4166 3.3 mg + Pembro
Participants received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG022
MK-4166 10 mg + Pembro
Participants received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG023
MK-4166 30 mg + Pembro
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG024
MK-4166 42 mg + Pembro
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG025
MK-4166 59 mg + Pembro
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG026
MK-4166 82 mg + Pembro
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG027
MK-4166 120 mg + Pembro
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG028
MK-4166 170 mg + Pembro
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG029
MK-4166 240 mg + Pembro
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG030
MK-4166 340 mg + Pembro
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG031
MK-4166 480 mg + Pembro
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG032
MK-4166 670 mg + Pembro
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG033
MK-4166 900 mg + Pembro
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Title
Denominators
Categories
Cycle 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Secondary
Apparent Volume of Distribution (V) of Pembrolizumab Over Time
Blood samples were collected at pre-specified time points during Cycles 1-4 from MK-4166 plus pembrolizumab combination cohorts only and plasma isolated for analysis of pembrolizumab V. V was defined as the theoretical volume that would be necessary to contain the total amount of administered pembrolizumab at the same concentration that it is observed in the blood plasma. Pembrolizumab V was reported by dose cohort for all participants that received MK-4166 plus pembrolizumab combination therapy. Per protocol, participants receiving MK-4166 monotherapy were excluded from this analysis.
All allocated participants who received ≥1 dose of pembrolizumab and had evaluable V samples. Per protocol, %GCV values were not reported for cohorts with n<2 participants, and MK-4166 monotherapy dose cohorts were not analyzed. Participants with samples that were hemolyzed or analyzed outside of stability were excluded from the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liters
Cycles 1-4: Day 1 pre-dose, at end of pembro infusion (up to 10 minutes), at end of MK-4166 infusion (up to 10 minutes), ~2 hours after start of MK-4166 infusion, Days 2, 3, 8, 15. Each cycle was 21 days. (Up to ~3 months)
ID
Title
Description
OG000
MK-4166 0.0015 mg
Participant received 0.0015 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG001
MK-4166 0.0045 mg
Participant received 0.0045 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG002
MK-4166 0.014 mg
Participant received 0.014 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG003
MK-4166 0.04 mg
Participant received 0.04 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG004
MK-4166 0.12 mg
Participant received 0.12 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG005
MK-4166 0.37 mg
Participant received 0.37 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG006
MK-4166 1.1 mg
Participant received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG007
MK-4166 3.3 mg
Participant received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG008
MK-4166 10 mg
Participant received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG009
MK-4166 30 mg
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG010
MK-4166 42 mg
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG011
MK-4166 59 mg
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG012
MK-4166 82 mg
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG013
MK-4166 120 mg
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG014
MK-4166 170 mg
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG015
MK-4166 240 mg
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG016
MK-4166 340 mg
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG017
MK-4166 480 mg
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG018
MK-4166 670 mg
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG019
MK-4166 900 mg
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG020
MK-4166 1.1 mg + Pembro
Participants received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG021
MK-4166 3.3 mg + Pembro
Participants received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG022
MK-4166 10 mg + Pembro
Participants received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG023
MK-4166 30 mg + Pembro
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG024
MK-4166 42 mg + Pembro
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG025
MK-4166 59 mg + Pembro
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG026
MK-4166 82 mg + Pembro
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG027
MK-4166 120 mg + Pembro
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG028
MK-4166 170 mg + Pembro
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG029
MK-4166 240 mg + Pembro
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG030
MK-4166 340 mg + Pembro
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG031
MK-4166 480 mg + Pembro
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG032
MK-4166 670 mg + Pembro
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG033
MK-4166 900 mg + Pembro
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Title
Denominators
Categories
Cycle 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Secondary
Glucocorticoid-Induced Tumor Necrosis Factor Receptor-Related Protein (GITR) Receptor Availability Following MK-4166 Administration
GITR protein receptor is internalized upon binding by MK-4166. To evaluate GITR target engagement, a GITR receptor availability assay was developed to assess the availability of cell surface GITR following administration of MK-4166. GITR was detected on CD4+CD25+ and CD4+CD95+ T-cell sub-populations in peripheral blood using flow cytometry. GITR receptor availability on representative CD4+ CD25+ T cell subsets following MK-4166 administration was reported over time for each dose cohort.
All allocated participants who received at least 1 dose of MK-4166 and had evaluable flow cytometry data.
Posted
Mean
Standard Deviation
Percentage GITR receptor availability
Cycle 1 Day 1: at end of infusion (up to 10 minutes), 2 hours post-infusion, Cycle 1 Days 2, 3, 5, 8, 15, Cycle 2 Day 1 pre-dose. Each cycle was 21 days.
ID
Title
Description
OG000
MK-4166 0.0015 mg
Participant received 0.0015 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG001
MK-4166 0.0045 mg
Participant received 0.0045 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG002
MK-4166 0.014 mg
Participant received 0.014 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG003
MK-4166 0.04 mg
Participant received 0.04 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG004
MK-4166 0.12 mg
Participant received 0.12 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG005
MK-4166 0.37 mg
Participant received 0.37 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG006
MK-4166 1.1 mg
Participant received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG007
MK-4166 3.3 mg
Participants received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG008
MK-4166 10 mg
Participant received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG009
MK-4166 30 mg
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG010
MK-4166 42 mg
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG011
MK-4166 59 mg
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG012
MK-4166 82 mg
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG013
MK-4166 120 mg
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG014
MK-4166 170 mg
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG015
MK-4166 240 mg
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG016
MK-4166 340 mg
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG017
MK-4166 480 mg
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG018
MK-4166 670 mg
Participant received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG019
MK-4166 900 mg
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
OG020
MK-4166 1.1 mg + Pembro
Participants received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG021
MK-4166 3.3 mg + Pembro
Participants received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG022
MK-4166 10 mg + Pembro
Participants received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG023
MK-4166 30 mg + Pembro
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG024
MK-4166 42 mg + Pembro
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG025
MK-4166 59 mg + Pembro
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG026
MK-4166 82 mg + Pembro
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG027
MK-4166 120 mg + Pembro
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG028
MK-4166 170 mg + Pembro
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG029
MK-4166 240 mg + Pembro
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG030
MK-4166 340 mg + Pembro
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG031
MK-4166 480 mg + Pembro
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG032
MK-4166 670 mg + Pembro
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
OG033
MK-4166 900 mg + Pembro
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
Units
Counts
Participants
OG0001
OG0010
OG0021
OG003
Title
Denominators
Categories
Cycle 1:Day 1; End of Infusion
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG003
16
50
6
48
43
48
EG001
MK-4166 + Pembro
All participants that received MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles (according to assigned dose) plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles (according to assigned doses).
13
66
21
65
63
65
EG002
MK-4166 0.0015 mg
Participant received 0.0015 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
0
1
0
1
0
1
EG003
MK-4166 0.0045 mg
Participant received 0.0045 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
1
1
1
1
1
1
EG004
MK-4166 0.014 mg
Participant received 0.014 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
1
1
0
1
1
1
EG005
MK-4166 0.04 mg
Participant received 0.04 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
0
1
0
1
1
1
EG006
MK-4166 0.12 mg
Participant received 0.12 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
0
1
0
1
1
1
EG007
MK-4166 0.37 mg
Participant received 0.37 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
0
1
0
1
1
1
EG008
MK-4166 1.1 mg
Participant received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
0
1
0
1
1
1
EG009
MK-4166 3.3 mg
Participant received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
1
1
0
1
1
1
EG010
MK-4166 10 mg
Participant received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
0
1
0
1
1
1
EG011
MK-4166 30 mg
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
3
6
2
6
4
6
EG012
MK-4166 42 mg
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
0
3
0
3
3
3
EG013
MK-4166 59 mg
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
1
3
0
3
3
3
EG014
MK-4166 82 mg
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
0
4
0
3
2
3
EG015
MK-4166 120 mg
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
1
3
0
3
2
3
EG016
MK-4166 170 mg
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
1
3
0
3
3
3
EG017
MK-4166 240 mg
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
2
5
0
5
5
5
EG018
MK-4166 340 mg
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
1
4
1
4
4
4
EG019
MK-4166 480 mg
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
1
3
2
3
3
3
EG020
MK-4166 670 mg
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
1
3
0
3
3
3
EG021
MK-4166 900 mg
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles.
2
4
0
3
3
3
EG022
MK-4166 1.1 mg + Pembro
Participants received 1.1 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
0
3
1
3
3
3
EG023
MK-4166 3.3 mg + Pembro
Participants received 3.3 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
1
5
1
4
3
4
EG024
MK-4166 10 mg + Pembro
Participants received 10 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
1
3
1
3
3
3
EG025
MK-4166 30 mg + Pembro
Participants received 30 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
0
3
0
3
3
3
EG026
MK-4166 42 mg + Pembro
Participants received 42 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
0
3
2
3
3
3
EG027
MK-4166 59 mg + Pembro
Participants received 59 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
2
3
3
3
3
3
EG028
MK-4166 82 mg + Pembro
Participants received 82 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
2
4
1
4
4
4
EG029
MK-4166 120 mg + Pembro
Participants received 120 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
0
3
0
3
3
3
EG030
MK-4166 170 mg + Pembro
Participants received 170 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
0
3
0
3
3
3
EG031
MK-4166 240 mg + Pembro
Participants received 240 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
0
3
1
3
3
3
EG032
MK-4166 340 mg + Pembro
Participants received 340 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
1
3
1
3
3
3
EG033
MK-4166 480 mg + Pembro
Participants received 480 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
1
3
1
3
3
3
EG034
MK-4166 670 mg + Pembro
Participants received 670 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
2
4
2
4
4
4
EG035
MK-4166 900 mg + Pembro
Participants received 900 mg MK-4166 IV on Day 1 of each 21-day cycle for up to 4 cycles plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle for up to 35 cycles.
3
23
7
23
22
23
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0281 events1 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0111 events1 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Intestinal obstruction
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0261 events1 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Large intestinal obstruction
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0331 events1 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Oesophageal pain
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0181 events1 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Retroperitoneal haematoma
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0012 events2 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0221 events1 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0261 events1 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Cholangitis
Hepatobiliary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0013 events2 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0272 events1 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0321 events1 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Gastroenteritis norovirus
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0311 events1 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Pneumonia
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0271 events1 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Sepsis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0191 events1 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0341 events1 affected4 at risk
EG0350 events0 affected23 at risk
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Type 1 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0341 events1 affected4 at risk
EG0350 events0 affected23 at risk
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0014 events3 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0354 events3 affected23 at risk
Tumour necrosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0231 events1 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Cognitive disorder
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0191 events1 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Seizure
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0191 events1 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Adjustment disorder
Psychiatric disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Bladder perforation
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0111 events1 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Nephritis
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Renal failure
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0012 events2 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0272 events2 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0241 events1 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0271 events1 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
EG0006 events6 affected48 at risk
EG00113 events12 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0091 events1 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0131 events1 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0171 events1 affected5 at risk
EG0181 events1 affected4 at risk
EG0191 events1 affected3 at risk
EG0200 events0 affected3 at risk
EG0211 events1 affected3 at risk
EG0222 events2 affected3 at risk
EG0230 events0 affected4 at risk
EG0243 events2 affected3 at risk
EG0250 events0 affected3 at risk
EG0261 events1 affected3 at risk
EG0270 events0 affected3 at risk
EG0282 events2 affected4 at risk
EG0292 events2 affected3 at risk
EG0300 events0 affected3 at risk
EG0312 events2 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0231 events1 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Supraventricular tachycardia
Cardiac disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0301 events1 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Ear congestion
Ear and labyrinth disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0291 events1 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Ear pain
Ear and labyrinth disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0211 events1 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0291 events1 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Hyperthyroidism
Endocrine disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0321 events1 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Hypothyroidism
Endocrine disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG00110 events10 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0231 events1 affected4 at risk
EG0241 events1 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0301 events1 affected3 at risk
EG0313 events3 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0341 events1 affected4 at risk
EG0353 events3 affected23 at risk
Eye pruritus
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0171 events1 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Eye swelling
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0311 events1 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Vision blurred
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0002 events2 affected48 at risk
EG0014 events3 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0131 events1 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0211 events1 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0281 events1 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0322 events1 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Abdominal discomfort
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0111 events1 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Abdominal distension
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0003 events3 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0131 events1 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0211 events1 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG00010 events9 affected48 at risk
EG00113 events11 affected65 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected1 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0112 events2 affected6 at risk
EG0122 events1 affected3 at risk
EG0131 events1 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0171 events1 affected5 at risk
EG0181 events1 affected4 at risk
EG0190 events0 affected3 at risk
EG0201 events1 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0231 events1 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0261 events1 affected3 at risk
EG0273 events1 affected3 at risk
EG0281 events1 affected4 at risk
EG0291 events1 affected3 at risk
EG0300 events0 affected3 at risk
EG0313 events3 affected3 at risk
EG0321 events1 affected3 at risk
EG0330 events0 affected3 at risk
EG0341 events1 affected4 at risk
EG0351 events1 affected23 at risk
Abdominal pain lower
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0012 events2 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0291 events1 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0331 events1 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0002 events2 affected48 at risk
EG0013 events2 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0111 events1 affected6 at risk
EG0121 events1 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0353 events2 affected23 at risk
Ascites
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0004 events3 affected48 at risk
EG0012 events2 affected65 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected1 at risk
EG0042 events1 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0171 events1 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0241 events1 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0291 events1 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Constipation
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0007 events7 affected48 at risk
EG0019 events8 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0041 events1 affected1 at risk
EG0051 events1 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0131 events1 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0171 events1 affected5 at risk
EG0181 events1 affected4 at risk
EG0191 events1 affected3 at risk
EG0200 events0 affected3 at risk
EG0211 events1 affected3 at risk
EG0220 events0 affected3 at risk
EG0231 events1 affected4 at risk
EG0241 events1 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0301 events1 affected3 at risk
EG0312 events2 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0354 events3 affected23 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0003 events3 affected48 at risk
EG00115 events9 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0121 events1 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0151 events1 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0191 events1 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0222 events1 affected3 at risk
EG0230 events0 affected4 at risk
EG0242 events1 affected3 at risk
EG0254 events1 affected3 at risk
EG0260 events0 affected3 at risk
EG0271 events1 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0311 events1 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0355 events4 affected23 at risk
Dry mouth
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0002 events2 affected48 at risk
EG0016 events6 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0111 events1 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0211 events1 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0252 events2 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0301 events1 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0353 events3 affected23 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0191 events1 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0281 events1 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Dysphagia
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0002 events2 affected48 at risk
EG0012 events2 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0151 events1 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0181 events1 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0231 events1 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0291 events1 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0013 events2 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0131 events1 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0252 events1 affected3 at risk
EG0260 events0 affected3 at risk
EG0271 events1 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Gingival pain
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0251 events1 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Nausea
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG00010 events8 affected48 at risk
EG00117 events16 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0101 events1 affected1 at risk
EG0113 events2 affected6 at risk
EG0121 events1 affected3 at risk
EG0130 events0 affected3 at risk
EG0142 events1 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0181 events1 affected4 at risk
EG0190 events0 affected3 at risk
EG0201 events1 affected3 at risk
EG0210 events0 affected3 at risk
EG0221 events1 affected3 at risk
EG0231 events1 affected4 at risk
EG0242 events2 affected3 at risk
EG0252 events1 affected3 at risk
EG0262 events2 affected3 at risk
EG0270 events0 affected3 at risk
EG0281 events1 affected4 at risk
EG0291 events1 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0321 events1 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0356 events6 affected23 at risk
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0261 events1 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0091 events1 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Toothache
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0013 events3 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0261 events1 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0352 events2 affected23 at risk
Vomiting
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG00010 events6 affected48 at risk
EG00118 events13 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0112 events1 affected6 at risk
EG0122 events1 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0163 events1 affected3 at risk
EG0171 events1 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0201 events1 affected3 at risk
EG0210 events0 affected3 at risk
EG0222 events1 affected3 at risk
EG0230 events0 affected4 at risk
EG0241 events1 affected3 at risk
EG0252 events1 affected3 at risk
EG0262 events2 affected3 at risk
EG0271 events1 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0311 events1 affected3 at risk
EG0321 events1 affected3 at risk
EG0332 events2 affected3 at risk
EG0340 events0 affected4 at risk
EG0356 events3 affected23 at risk
Asthenia
General disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0191 events1 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Catheter site scar
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0301 events1 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Chest pain
General disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0014 events4 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0211 events1 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0241 events1 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0271 events1 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0352 events2 affected23 at risk
Chills
General disorders
MedDRA 22.1
Systematic Assessment
EG0004 events2 affected48 at risk
EG0013 events3 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0123 events1 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0201 events1 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0241 events1 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0271 events1 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0301 events1 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Early satiety
General disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0181 events1 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Fatigue
General disorders
MedDRA 22.1
Systematic Assessment
EG00015 events15 affected48 at risk
EG00142 events37 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0041 events1 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0112 events2 affected6 at risk
EG0121 events1 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0151 events1 affected3 at risk
EG0163 events3 affected3 at risk
EG0171 events1 affected5 at risk
EG0183 events3 affected4 at risk
EG0191 events1 affected3 at risk
EG0201 events1 affected3 at risk
EG0211 events1 affected3 at risk
EG0223 events3 affected3 at risk
EG0233 events3 affected4 at risk
EG0242 events2 affected3 at risk
EG0253 events3 affected3 at risk
EG0260 events0 affected3 at risk
EG0272 events2 affected3 at risk
EG0283 events2 affected4 at risk
EG0292 events2 affected3 at risk
EG0303 events2 affected3 at risk
EG0311 events1 affected3 at risk
EG0321 events1 affected3 at risk
EG0332 events2 affected3 at risk
EG0340 events0 affected4 at risk
EG03517 events14 affected23 at risk
Feeling hot
General disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0071 events1 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Generalised oedema
General disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0111 events1 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Malaise
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0271 events1 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Non-cardiac chest pain
General disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0012 events2 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0111 events1 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0321 events1 affected3 at risk
EG0330 events0 affected3 at risk
EG0341 events1 affected4 at risk
EG0350 events0 affected23 at risk
Oedema
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0241 events1 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Oedema peripheral
General disorders
MedDRA 22.1
Systematic Assessment
EG0003 events3 affected48 at risk
EG0012 events2 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0131 events1 affected3 at risk
EG0141 events1 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0211 events1 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0241 events1 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Pain
General disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0012 events2 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0211 events1 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0291 events1 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0331 events1 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Pyrexia
General disorders
MedDRA 22.1
Systematic Assessment
EG0006 events4 affected48 at risk
EG0018 events5 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0091 events1 affected1 at risk
EG0100 events0 affected1 at risk
EG0111 events1 affected6 at risk
EG0123 events1 affected3 at risk
EG0131 events1 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0253 events1 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0292 events1 affected3 at risk
EG0300 events0 affected3 at risk
EG0311 events1 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0352 events2 affected23 at risk
Bile duct obstruction
Hepatobiliary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0271 events1 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Hypersensitivity
Immune system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0311 events1 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Seasonal allergy
Immune system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0251 events1 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Bronchitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0181 events1 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Conjunctivitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0101 events1 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Cystitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0012 events2 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0061 events1 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0221 events1 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0311 events1 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Eye infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0131 events1 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Folliculitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0291 events1 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Influenza
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0311 events1 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Nasopharyngitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0014 events4 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0131 events1 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0354 events4 affected23 at risk
Oral candidiasis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0012 events2 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0181 events1 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0231 events1 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Oral infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0271 events1 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Pharyngitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0231 events1 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Pneumonia
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0291 events1 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Respiratory tract infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0251 events1 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Rhinitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0131 events1 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Sinusitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0131 events1 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Tooth abscess
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0281 events1 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0016 events6 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0356 events6 affected23 at risk
Urinary tract infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0003 events2 affected48 at risk
EG0012 events2 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0152 events1 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0191 events1 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0221 events1 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Viral infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0012 events2 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0352 events2 affected23 at risk
Animal bite
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0221 events1 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Gastrointestinal stoma complication
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0261 events1 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG00013 events9 affected48 at risk
EG00127 events22 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0121 events1 affected3 at risk
EG0134 events2 affected3 at risk
EG0140 events0 affected3 at risk
EG0151 events1 affected3 at risk
EG0162 events1 affected3 at risk
EG0172 events1 affected5 at risk
EG0181 events1 affected4 at risk
EG0190 events0 affected3 at risk
EG0201 events1 affected3 at risk
EG0211 events1 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0241 events1 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0283 events2 affected4 at risk
EG0291 events1 affected3 at risk
EG0300 events0 affected3 at risk
EG0312 events2 affected3 at risk
EG0324 events3 affected3 at risk
EG0330 events0 affected3 at risk
EG0343 events3 affected4 at risk
EG03513 events10 affected23 at risk
Wound dehiscence
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0291 events1 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Alanine aminotransferase increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0014 events4 affected65 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0271 events1 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0321 events1 affected3 at risk
EG0330 events0 affected3 at risk
EG0341 events1 affected4 at risk
EG0351 events1 affected23 at risk
Aspartate aminotransferase increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0341 events1 affected4 at risk
EG0350 events0 affected23 at risk
Blood alkaline phosphatase increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0002 events2 affected48 at risk
EG0012 events2 affected65 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0071 events1 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0321 events1 affected3 at risk
EG0330 events0 affected3 at risk
EG0341 events1 affected4 at risk
EG0350 events0 affected23 at risk
Blood bilirubin increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0012 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0322 events1 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Blood creatinine increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0012 events2 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0201 events1 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0281 events1 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Gamma-glutamyltransferase increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Lipase increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0012 events2 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0352 events2 affected23 at risk
Lymphocyte count decreased
Investigations
MedDRA 22.1
Systematic Assessment
EG0003 events1 affected48 at risk
EG0016 events6 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0203 events1 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0241 events1 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0271 events1 affected3 at risk
EG0281 events1 affected4 at risk
EG0291 events1 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0321 events1 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Neutrophil count increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0271 events1 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Weight decreased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0012 events2 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0281 events1 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Weight increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0014 events3 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0354 events3 affected23 at risk
Cachexia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0151 events1 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0008 events8 affected48 at risk
EG00112 events12 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0081 events1 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0113 events3 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0161 events1 affected3 at risk
EG0170 events0 affected5 at risk
EG0181 events1 affected4 at risk
EG0191 events1 affected3 at risk
EG0201 events1 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0231 events1 affected4 at risk
EG0241 events1 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0271 events1 affected3 at risk
EG0280 events0 affected4 at risk
EG0291 events1 affected3 at risk
EG0302 events2 affected3 at risk
EG0311 events1 affected3 at risk
EG0321 events1 affected3 at risk
EG0331 events1 affected3 at risk
EG0341 events1 affected4 at risk
EG0352 events2 affected23 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0012 events2 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0201 events1 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0282 events2 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Glucose tolerance impaired
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0141 events1 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0121 events1 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0231 events1 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0181 events1 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0003 events2 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0181 events1 affected4 at risk
EG0190 events0 affected3 at risk
EG0202 events1 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0331 events1 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0191 events1 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0002 events2 affected48 at risk
EG0012 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0181 events1 affected4 at risk
EG0190 events0 affected3 at risk
EG0201 events1 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0342 events1 affected4 at risk
EG0350 events0 affected23 at risk
Type 1 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0341 events1 affected4 at risk
EG0350 events0 affected23 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0003 events3 affected48 at risk
EG00110 events9 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0131 events1 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0171 events1 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0211 events1 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0301 events1 affected3 at risk
EG0312 events2 affected3 at risk
EG0321 events1 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0356 events5 affected23 at risk
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0002 events2 affected48 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0111 events1 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0211 events1 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0003 events3 affected48 at risk
EG00116 events13 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0112 events2 affected6 at risk
EG0121 events1 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0221 events1 affected3 at risk
EG0232 events2 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0261 events1 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0302 events1 affected3 at risk
EG0312 events1 affected3 at risk
EG0320 events0 affected3 at risk
EG0331 events1 affected3 at risk
EG0340 events0 affected4 at risk
EG0357 events6 affected23 at risk
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0191 events1 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0281 events1 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0013 events3 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0271 events1 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0352 events2 affected23 at risk
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0012 events2 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0352 events2 affected23 at risk
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0002 events2 affected48 at risk
EG0012 events2 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0121 events1 affected3 at risk
EG0131 events1 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0311 events1 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0003 events3 affected48 at risk
EG0013 events2 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0111 events1 affected6 at risk
EG0122 events2 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0251 events1 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0292 events1 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0014 events4 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0181 events1 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0251 events1 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0311 events1 affected3 at risk
EG0321 events1 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0012 events2 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0121 events1 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0251 events1 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0291 events1 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0061 events1 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0281 events1 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0002 events2 affected48 at risk
EG0014 events4 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0161 events1 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0211 events1 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0281 events1 affected4 at risk
EG0290 events0 affected3 at risk
EG0302 events2 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Amnesia
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0012 events2 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0352 events2 affected23 at risk
Dizziness
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0002 events2 affected48 at risk
EG0015 events5 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0161 events1 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0201 events1 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0291 events1 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0354 events4 affected23 at risk
Dysgeusia
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0002 events2 affected48 at risk
EG0012 events2 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0081 events1 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0211 events1 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0311 events1 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Dysmetria
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0211 events1 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Headache
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0014 events4 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0221 events1 affected3 at risk
EG0231 events1 affected4 at risk
EG0240 events0 affected3 at risk
EG0252 events2 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Lethargy
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0012 events2 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0241 events1 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Motor dysfunction
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0211 events1 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Neuropathy peripheral
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0221 events1 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Peripheral motor neuropathy
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0161 events1 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0003 events2 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0142 events1 affected3 at risk
EG0150 events0 affected3 at risk
EG0161 events1 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0291 events1 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Presyncope
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0211 events1 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Restless legs syndrome
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0251 events1 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Seizure
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0191 events1 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Syncope
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0171 events1 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Trigeminal nerve disorder
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0281 events1 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Anxiety
Psychiatric disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0111 events1 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0301 events1 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Depression
Psychiatric disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0231 events1 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Insomnia
Psychiatric disorders
MedDRA 22.1
Systematic Assessment
EG0004 events4 affected48 at risk
EG0013 events3 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0061 events1 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0111 events1 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0191 events1 affected3 at risk
EG0200 events0 affected3 at risk
EG0211 events1 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0291 events1 affected3 at risk
EG0301 events1 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Micturition urgency
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0012 events2 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0171 events1 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0292 events2 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Pollakiuria
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0241 events1 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Urinary incontinence
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0131 events1 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Urinary tract obstruction
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0221 events1 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Breast pain
Reproductive system and breast disorders
MedDRA 22.1
Systematic Assessment
EG0002 events2 affected48 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0191 events1 affected3 at risk
EG0200 events0 affected3 at risk
EG0211 events1 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Dyspareunia
Reproductive system and breast disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0151 events1 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Menorrhagia
Reproductive system and breast disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0013 events2 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0241 events1 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0292 events1 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0281 events1 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Vulvovaginal rash
Reproductive system and breast disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0311 events1 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0231 events1 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0005 events5 affected48 at risk
EG00112 events9 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0111 events1 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0171 events1 affected5 at risk
EG0181 events1 affected4 at risk
EG0191 events1 affected3 at risk
EG0201 events1 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0241 events1 affected3 at risk
EG0252 events1 affected3 at risk
EG0261 events1 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0291 events1 affected3 at risk
EG0301 events1 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0342 events1 affected4 at risk
EG0354 events3 affected23 at risk
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0002 events2 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0182 events2 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0331 events1 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0007 events7 affected48 at risk
EG00111 events11 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0061 events1 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0101 events1 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0131 events1 affected3 at risk
EG0140 events0 affected3 at risk
EG0151 events1 affected3 at risk
EG0160 events0 affected3 at risk
EG0171 events1 affected5 at risk
EG0181 events1 affected4 at risk
EG0191 events1 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0221 events1 affected3 at risk
EG0231 events1 affected4 at risk
EG0240 events0 affected3 at risk
EG0252 events2 affected3 at risk
EG0260 events0 affected3 at risk
EG0272 events2 affected3 at risk
EG0280 events0 affected4 at risk
EG0291 events1 affected3 at risk
EG0301 events1 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0331 events1 affected3 at risk
EG0340 events0 affected4 at risk
EG0352 events2 affected23 at risk
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0251 events1 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0301 events1 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0012 events2 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0211 events1 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0241 events1 affected3 at risk
EG0250 events0 affected3 at risk
EG0261 events1 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Nasal crusting
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0251 events1 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0013 events3 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0251 events1 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0352 events2 affected23 at risk
Orthopnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0211 events1 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0002 events2 affected48 at risk
EG0012 events2 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0111 events1 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0181 events1 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0271 events1 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0171 events1 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0261 events1 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0013 events3 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0251 events1 affected3 at risk
EG0260 events0 affected3 at risk
EG0271 events1 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0321 events1 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Respiratory symptom
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0181 events1 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0321 events1 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0111 events1 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0002 events2 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0171 events1 affected5 at risk
EG0180 events0 affected4 at risk
EG0191 events1 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0291 events1 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0014 events3 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0292 events1 affected3 at risk
EG0301 events1 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0012 events2 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0201 events1 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0281 events1 affected4 at risk
EG0291 events1 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Erythema
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0012 events2 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0291 events1 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Hirsutism
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0191 events1 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0003 events3 affected48 at risk
EG0012 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0071 events1 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0141 events1 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0201 events1 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0352 events1 affected23 at risk
Palmar erythema
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0071 events1 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0009 events7 affected48 at risk
EG00118 events15 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0121 events1 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0162 events1 affected3 at risk
EG0171 events1 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0201 events1 affected3 at risk
EG0213 events2 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0251 events1 affected3 at risk
EG0261 events1 affected3 at risk
EG0272 events1 affected3 at risk
EG0282 events2 affected4 at risk
EG0292 events2 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0321 events1 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0359 events7 affected23 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0017 events5 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0161 events1 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0357 events5 affected23 at risk
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0017 events6 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0161 events1 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0251 events1 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0292 events1 affected3 at risk
EG0300 events0 affected3 at risk
EG0311 events1 affected3 at risk
EG0322 events2 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Skin mass
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0291 events1 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0291 events1 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0271 events1 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Vitiligo
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0251 events1 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Deep vein thrombosis
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0321 events1 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Hot flush
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0015 events3 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0161 events1 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0261 events1 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0354 events2 affected23 at risk
Hypertension
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0161 events1 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Hypotension
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0141 events1 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Lymphoedema
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0181 events1 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0291 events1 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Venous thrombosis
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0261 events1 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0350 events0 affected23 at risk
Hypophysitis
Endocrine disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Cataract
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Conjunctival hyperaemia
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Dry eye
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Eye inflammation
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Eye pain
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Ocular hyperaemia
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Angina bullosa haemorrhagica
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Colitis
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Faeces discoloured
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Frequent bowel movements
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0012 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0352 events1 affected23 at risk
Hyperaesthesia teeth
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Influenza like illness
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Localised oedema
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Contrast media reaction
Immune system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Bronchiolitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Ear infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0012 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0352 events1 affected23 at risk
Gingivitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Herpes ophthalmic
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Lower respiratory tract infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Otitis externa
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Viral upper respiratory tract infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Contusion
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Epicondylitis
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Meniscus injury
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Skin laceration
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Sunburn
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Amylase increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Intervertebral disc compression
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Joint stiffness
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0012 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0352 events1 affected23 at risk
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Limb discomfort
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Spondylolisthesis
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Tendon pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Sinus headache
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Nocturia
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Throat tightness
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Menopause
Social circumstances
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
Flushing
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected3 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected5 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected3 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected3 at risk
EG0230 events0 affected4 at risk
EG0240 events0 affected3 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected3 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected4 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected3 at risk
EG0310 events0 affected3 at risk
EG0320 events0 affected3 at risk
EG0330 events0 affected3 at risk
EG0340 events0 affected4 at risk
EG0351 events1 affected23 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
0
BG0050
BG0060
BG0070
BG0081
BG0093
BG0102
BG0110
BG0121
BG0132
BG0141
BG0154
BG0162
BG0171
BG0182
BG0191
BG0201
BG0214
BG0221
BG0231
BG0241
BG0251
BG0261
BG0270
BG0281
BG0291
BG0302
BG0311
BG0323
BG03317
BG03458
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
BG0190
BG0200
BG0210
BG0220
BG0230
BG0240
BG0250
BG0260
BG0270
BG0280
BG0290
BG0300
BG0310
BG0320
BG0330
BG0340
1
BG0051
BG0061
BG0071
BG0081
BG0096
BG0103
BG0113
BG0124
BG0133
BG0143
BG0155
BG0164
BG0173
BG0183
BG0194
BG0203
BG0215
BG0223
BG0233
BG0243
BG0253
BG0264
BG0273
BG0283
BG0293
BG0303
BG0313
BG0324
BG03323
BG034116
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
BG0190
BG0200
BG0210
BG0220
BG0230
BG0240
BG0250
BG0260
BG0270
BG0280
BG0290
BG0300
BG0310
BG0320
BG0330
BG0340
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
BG0190
BG0200
BG0210
BG0220
BG0230
BG0240
BG0250
BG0260
BG0270
BG0280
BG0290
BG0300
BG0310
BG0320
BG0330
BG0340
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
BG0190
BG0200
BG0210
BG0220
BG0230
BG0240
BG0250
BG0260
BG0270
BG0280
BG0290
BG0300
BG0310
BG0320
BG0330
BG0340
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
BG0190
BG0200
BG0210
BG0220
BG0230
BG0240
BG0250
BG0260
BG0270
BG0280
BG0290
BG0300
BG0310
BG0320
BG0330
BG0340
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
BG0190
BG0200
BG0210
BG0220
BG0230
BG0240
BG0250
BG0260
BG0270
BG0280
BG0290
BG0300
BG0310
BG0320
BG0330
BG0340
1
BG0051
BG0061
BG0071
BG0081
BG0096
BG0103
BG0113
BG0124
BG0133
BG0143
BG0155
BG0164
BG0173
BG0183
BG0194
BG0203
BG0215
BG0223
BG0233
BG0243
BG0253
BG0264
BG0273
BG0283
BG0293
BG0303
BG0313
BG0324
BG03323
BG034116
1
OG0041
OG0051
OG0061
OG0071
OG0081
OG0091
OG0101
OG0116
OG0123
OG0133
OG0143
OG0153
OG0163
OG0175
OG0184
OG0193
OG0203
OG0213
OG0223
OG0234
OG0243
OG0253
OG0263
OG0273
OG0284
OG0293
OG0303
OG0313
OG0323
OG0333
OG0344
OG03523
1
OG0041
OG0051
OG0061
OG0071
OG0081
OG0091
OG0101
OG0115
OG0123
OG0133
OG0142
OG0152
OG0163
OG0175
OG0184
OG0193
OG0203
OG0213
OG0223
OG0233
OG0243
OG0253
OG0263
OG0273
OG0284
OG0293
OG0303
OG0313
OG0323
OG0333
OG0344
OG03522
1
OG0041
OG0051
OG0061
OG0071
OG0081
OG0091
OG0101
OG0116
OG0123
OG0133
OG0143
OG0153
OG0163
OG0175
OG0184
OG0193
OG0203
OG0213
OG0223
OG0234
OG0243
OG0253
OG0263
OG0273
OG0284
OG0293
OG0303
OG0313
OG0323
OG0333
OG0344
OG03523
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG0140
OG0150
OG0160
OG0171
OG0180
OG0191
OG0200
OG0210
OG0220
OG0230
OG0240
OG0250
OG0260
OG0271
OG0281
OG0290
OG0300
OG0310
OG0321
OG0330
OG0341
OG0354
1
OG0041
OG0051
OG0061
OG0071
OG0081
OG0096
OG0103
OG0113
OG0123
OG0133
OG0143
OG0155
OG0164
OG0173
OG0183
OG0193
OG0203
OG0214
OG0223
OG0233
OG0243
OG0253
OG0264
OG0273
OG0283
OG0293
OG0303
OG0313
OG0324
OG03323
1
ParticipantsOG0041
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0071
ParticipantsOG0081
ParticipantsOG0096
ParticipantsOG0103
ParticipantsOG0113
ParticipantsOG0123
ParticipantsOG0133
ParticipantsOG0143
ParticipantsOG0155
ParticipantsOG0164
ParticipantsOG0173
ParticipantsOG0183
ParticipantsOG0193
ParticipantsOG0203
ParticipantsOG0214
ParticipantsOG0223
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0253
ParticipantsOG0264
ParticipantsOG0273
ParticipantsOG0283
ParticipantsOG0293
ParticipantsOG0303
ParticipantsOG0313
ParticipantsOG0324
ParticipantsOG03323
Title
Measurements
OG0000.536± NANA = %GCV values were not reported when n\<2.
OG0015.18± NANA = %GCV values were not reported when n\<2.
OG00217.3± NANA = %GCV values were not reported when n\<2.
OG00321.1± NANA = %GCV values were not reported when n\<2.
OG00434.3± NANA = %GCV values were not reported when n\<2.
OG005205± NANA = %GCV values were not reported when n\<2.
OG006585± NANA = %GCV values were not reported when n\<2.
OG0071580± NANA = %GCV values were not reported when n\<2.
OG0083550± NANA = %GCV values were not reported when n\<2.
OG00910900± 37.1
OG01012300± 21.8
OG01121800± 13.3
OG01223300± 40.7
OG01338100± 28.5
OG01458600± 16.2
OG01568600± 25.1
OG01696500± 25.8
OG017149000± 16.6
OG018195000± 44.4
OG019301000± 18.8
OG0201790± 16.6
OG0213670± 72.9
OG0225010± 39.7
OG02316300± 32.2
OG02416900± 51.1
OG02520400± 5.75
OG02626300± 32.1
OG02728300± 44.5
OG02855200± 17.2
OG02985900± 12.7
OG030109000± 8.9
OG031144000± 2.8
OG032210000± 11.8
OG033234000± 22.7
Cycle 2
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
ParticipantsOG0041
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0071
ParticipantsOG0081
ParticipantsOG0094
ParticipantsOG0103
ParticipantsOG0112
ParticipantsOG0123
ParticipantsOG0133
ParticipantsOG0143
ParticipantsOG0152
ParticipantsOG0163
ParticipantsOG0173
ParticipantsOG0183
ParticipantsOG0193
ParticipantsOG0203
ParticipantsOG0213
ParticipantsOG0223
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0252
ParticipantsOG0263
ParticipantsOG0273
ParticipantsOG0283
ParticipantsOG0293
ParticipantsOG0303
ParticipantsOG0312
ParticipantsOG0322
ParticipantsOG03323
Title
Measurements
OG0000.0225± NANA = %GCV values were not reported when n\<2.
OG00348.2± NANA = %GCV values were not reported when n\<2.
OG00450.2± NANA = %GCV values were not reported when n\<2.
OG005
Cycle 3
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0041
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0094
ParticipantsOG0103
ParticipantsOG0112
ParticipantsOG0123
ParticipantsOG0133
ParticipantsOG0143
ParticipantsOG0152
ParticipantsOG0163
ParticipantsOG0171
ParticipantsOG0181
ParticipantsOG0193
ParticipantsOG0203
ParticipantsOG0213
ParticipantsOG0222
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0252
ParticipantsOG0263
ParticipantsOG0273
ParticipantsOG0283
ParticipantsOG0293
ParticipantsOG0303
ParticipantsOG0312
ParticipantsOG0322
ParticipantsOG03318
Title
Measurements
OG0000.767± NANA = %GCV values were not reported when n\<2.
OG00468.8± NANA = %GCV values were not reported when n\<2.
OG008179± NANA = %GCV values were not reported when n\<2.
OG009
Cycle 4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0102
ParticipantsOG0112
ParticipantsOG0122
ParticipantsOG0132
ParticipantsOG0142
ParticipantsOG0152
ParticipantsOG0162
ParticipantsOG0170
ParticipantsOG0181
ParticipantsOG0191
ParticipantsOG0201
ParticipantsOG0210
ParticipantsOG0221
ParticipantsOG0232
ParticipantsOG0242
ParticipantsOG0252
ParticipantsOG0260
ParticipantsOG0273
ParticipantsOG0281
ParticipantsOG0292
ParticipantsOG0301
ParticipantsOG0310
ParticipantsOG0322
ParticipantsOG03318
Title
Measurements
OG0107870± 126.1
OG01113100± 115.8
OG01220800± 44.2
OG013
1
OG0041
OG0051
OG0061
OG0071
OG0081
OG0096
OG0103
OG0113
OG0123
OG0133
OG0143
OG0155
OG0164
OG0173
OG0183
OG0193
OG0203
OG0214
OG0223
OG0233
OG0243
OG0253
OG0264
OG0273
OG0283
OG0293
OG0303
OG0313
OG0324
OG03323
1
ParticipantsOG0041
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0071
ParticipantsOG0081
ParticipantsOG0096
ParticipantsOG0103
ParticipantsOG0113
ParticipantsOG0123
ParticipantsOG0133
ParticipantsOG0143
ParticipantsOG0155
ParticipantsOG0164
ParticipantsOG0173
ParticipantsOG0183
ParticipantsOG0193
ParticipantsOG0203
ParticipantsOG0214
ParticipantsOG0223
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0253
ParticipantsOG0264
ParticipantsOG0273
ParticipantsOG0283
ParticipantsOG0293
ParticipantsOG0303
ParticipantsOG0313
ParticipantsOG0324
ParticipantsOG03323
Title
Measurements
OG0000.96(0.96 to 0.96)
OG0010.03(0.03 to 0.03)
OG0020.03(0.03 to 0.03)
OG0030.03(0.03 to 0.03)
OG0040.03(0.03 to 0.03)
OG0050.03(0.03 to 0.03)
OG0060.08(0.08 to 0.08)
OG0070.02(0.02 to 0.02)
OG0080.08(0.08 to 0.08)
OG0090.05(0.02 to 0.08)
OG0100.03(0.02 to 0.08)
OG0110.02(0.02 to 0.03)
OG0120.02(0.02 to 0.03)
OG0130.03(0.02 to 0.07)
OG0140.03(0.02 to 0.03)
OG0150.03(0.02 to 1.10)
OG0160.02(0.02 to 1.11)
OG0170.03(0.02 to 0.08)
OG0180.02(0.02 to 0.08)
OG0190.08(0.02 to 1.06)
OG0200.03(0.03 to 0.08)
OG0210.03(0.03 to 0.08)
OG0220.08(0.03 to 0.09)
OG0230.08(0.03 to 0.09)
OG0240.02(0.02 to 0.08)
OG0250.03(0.02 to 0.08)
OG0260.04(0.02 to 0.08)
OG0270.03(0.02 to 0.09)
OG0280.08(0.02 to 0.08)
OG0290.04(0.03 to 0.08)
OG0300.03(0.02 to 0.09)
OG0310.08(0.02 to 0.09)
OG0320.05(0.02 to 0.13)
OG0330.08(0.02 to 0.13)
Cycle 2
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
ParticipantsOG0041
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0071
ParticipantsOG0081
ParticipantsOG0094
ParticipantsOG0103
ParticipantsOG0112
ParticipantsOG0123
ParticipantsOG0133
ParticipantsOG0143
ParticipantsOG0152
ParticipantsOG0163
ParticipantsOG0173
ParticipantsOG0183
ParticipantsOG0193
ParticipantsOG0203
ParticipantsOG0213
ParticipantsOG0223
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0252
ParticipantsOG0263
ParticipantsOG0273
ParticipantsOG0283
ParticipantsOG0293
ParticipantsOG0303
ParticipantsOG0312
ParticipantsOG0322
ParticipantsOG03323
Title
Measurements
OG0006.98(6.98 to 6.98)
OG0030.03(0.03 to 0.03)
OG0040.04(0.04 to 0.04)
OG005
Cycle 3
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0041
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0094
ParticipantsOG0103
ParticipantsOG0112
ParticipantsOG0123
ParticipantsOG0133
ParticipantsOG0143
ParticipantsOG0152
ParticipantsOG0163
ParticipantsOG0171
ParticipantsOG0181
ParticipantsOG0193
ParticipantsOG0203
ParticipantsOG0213
ParticipantsOG0222
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0252
ParticipantsOG0263
ParticipantsOG0273
ParticipantsOG0283
ParticipantsOG0293
ParticipantsOG0303
ParticipantsOG0312
ParticipantsOG0322
ParticipantsOG03318
Title
Measurements
OG0000.08(0.08 to 0.08)
OG0040.04(0.04 to 0.04)
OG0080.03(0.03 to 0.03)
OG009
Cycle 4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0102
ParticipantsOG0112
ParticipantsOG0122
ParticipantsOG0132
ParticipantsOG0142
ParticipantsOG0152
ParticipantsOG0162
ParticipantsOG0170
ParticipantsOG0181
ParticipantsOG0191
ParticipantsOG0201
ParticipantsOG0210
ParticipantsOG0221
ParticipantsOG0232
ParticipantsOG0242
ParticipantsOG0252
ParticipantsOG0260
ParticipantsOG0273
ParticipantsOG0281
ParticipantsOG0292
ParticipantsOG0301
ParticipantsOG0310
ParticipantsOG0322
ParticipantsOG03318
Title
Measurements
OG0100.06(0.03 to 0.08)
OG0110.03(0.02 to 0.03)
OG0120.02(0.02 to 0.02)
OG013
1
OG0041
OG0051
OG0061
OG0071
OG0081
OG0096
OG0103
OG0113
OG0123
OG0133
OG0143
OG0155
OG0164
OG0173
OG0183
OG0193
OG0203
OG0214
OG0223
OG0233
OG0243
OG0253
OG0264
OG0273
OG0283
OG0293
OG0303
OG0313
OG0324
OG03323
1
ParticipantsOG0041
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0071
ParticipantsOG0081
ParticipantsOG0096
ParticipantsOG0103
ParticipantsOG0113
ParticipantsOG0123
ParticipantsOG0133
ParticipantsOG0143
ParticipantsOG0155
ParticipantsOG0164
ParticipantsOG0173
ParticipantsOG0183
ParticipantsOG0193
ParticipantsOG0203
ParticipantsOG0214
ParticipantsOG0223
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0253
ParticipantsOG0263
ParticipantsOG0273
ParticipantsOG0283
ParticipantsOG0293
ParticipantsOG0303
ParticipantsOG0312
ParticipantsOG0324
ParticipantsOG03323
Title
Measurements
OG0002.61± NANA = %GCV values were not reported when n\<2.
OG0012.74± NANA = %GCV values were not reported when n\<2.
OG0022.68± NANA = %GCV values were not reported when n\<2.
OG0033.48± NANA = %GCV values were not reported when n\<2.
OG0042.73± NANA = %GCV values were not reported when n\<2.
OG0052.10± NANA = %GCV values were not reported when n\<2.
OG0063.39± NANA = %GCV values were not reported when n\<2.
OG0073.30± NANA = %GCV values were not reported when n\<2.
OG0087.62± NANA = %GCV values were not reported when n\<2.
OG0097.7± 67.2
OG0107.49± 107.2
OG0112.93± 85.2
OG01212.8± 27.6
OG0136.37± 87.7
OG0147.66± 31.4
OG0155.17± 126.5
OG01612.0± 69.2
OG01711.3± 22.7
OG01813.1± 37.2
OG01912.3± 4.5
OG0202.86± 9.63
OG0213.64± 27.7
OG0226.15± 78.5
OG02312.0± 60.9
OG0247.31± 48.9
OG0258.60± 66.6
OG0268.84± 14.3
OG02710.9± 28.8
OG02811.9± 12.0
OG02913.0± 10.6
OG0307.81± 120.0
OG03113.4± 37.4
OG0329.03± 77.4
OG03312.0± 70.1
Cycle 2
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
ParticipantsOG0041
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0071
ParticipantsOG0081
ParticipantsOG0094
ParticipantsOG0103
ParticipantsOG0112
ParticipantsOG0123
ParticipantsOG0133
ParticipantsOG0142
ParticipantsOG0152
ParticipantsOG0163
ParticipantsOG0172
ParticipantsOG0183
ParticipantsOG0192
ParticipantsOG0203
ParticipantsOG0213
ParticipantsOG0222
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0252
ParticipantsOG0263
ParticipantsOG0273
ParticipantsOG0283
ParticipantsOG0293
ParticipantsOG0303
ParticipantsOG0312
ParticipantsOG0322
ParticipantsOG03320
Title
Measurements
OG000NA± NANA = t½ was not calculable.
OG0032.31± NANA = %GCV values were not reported when n\<2.
OG0043.22± NANA = %GCV values were not reported when n\<2.
OG005
Cycle 3
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0041
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0093
ParticipantsOG0103
ParticipantsOG0111
ParticipantsOG0123
ParticipantsOG0133
ParticipantsOG0143
ParticipantsOG0152
ParticipantsOG0163
ParticipantsOG0171
ParticipantsOG0181
ParticipantsOG0192
ParticipantsOG0203
ParticipantsOG0212
ParticipantsOG0221
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0252
ParticipantsOG0263
ParticipantsOG0273
ParticipantsOG0283
ParticipantsOG0293
ParticipantsOG0303
ParticipantsOG0311
ParticipantsOG0322
ParticipantsOG03318
Title
Measurements
OG0003.34± NANA = %GCV values were not reported when n\<2.
OG0041.76± NANA = %GCV values were not reported when n\<2.
OG008NA± NANA = t½ was not calculable.
OG009
Cycle 4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0102
ParticipantsOG0111
ParticipantsOG0122
ParticipantsOG0132
ParticipantsOG0142
ParticipantsOG0152
ParticipantsOG0161
ParticipantsOG0170
ParticipantsOG0181
ParticipantsOG0191
ParticipantsOG0201
ParticipantsOG0210
ParticipantsOG0221
ParticipantsOG0232
ParticipantsOG0241
ParticipantsOG0252
ParticipantsOG0260
ParticipantsOG0273
ParticipantsOG0281
ParticipantsOG0292
ParticipantsOG0301
ParticipantsOG0310
ParticipantsOG0321
ParticipantsOG03316
Title
Measurements
OG0102.04± 706.9
OG0118.79± NANA = %GCV values were not reported when n\<2.
OG0122.59± 220.3
OG013
1
OG0041
OG0051
OG0061
OG0071
OG0081
OG0096
OG0103
OG0113
OG0123
OG0133
OG0143
OG0155
OG0164
OG0173
OG0183
OG0193
OG0203
OG0214
OG0223
OG0233
OG0243
OG0253
OG0264
OG0273
OG0283
OG0293
OG0303
OG0313
OG0324
OG03323
1
ParticipantsOG0041
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0071
ParticipantsOG0081
ParticipantsOG0096
ParticipantsOG0103
ParticipantsOG0113
ParticipantsOG0123
ParticipantsOG0133
ParticipantsOG0143
ParticipantsOG0155
ParticipantsOG0164
ParticipantsOG0173
ParticipantsOG0183
ParticipantsOG0193
ParticipantsOG0203
ParticipantsOG0214
ParticipantsOG0223
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0253
ParticipantsOG0263
ParticipantsOG0273
ParticipantsOG0283
ParticipantsOG0293
ParticipantsOG0303
ParticipantsOG0312
ParticipantsOG0324
ParticipantsOG03323
Title
Measurements
OG0001.08± NANA = %GCV values were not reported when n\<2.
OG0013.91± NANA = %GCV values were not reported when n\<2.
OG00224.7± NANA = %GCV values were not reported when n\<2.
OG00339.0± NANA = %GCV values were not reported when n\<2.
OG00469.4± NANA = %GCV values were not reported when n\<2.
OG005672± NANA = %GCV values were not reported when n\<2.
OG0063140± NANA = %GCV values were not reported when n\<2.
OG0078300± NANA = %GCV values were not reported when n\<2.
OG00819100± NANA = %GCV values were not reported when n\<2.
OG00984700± 36.5
OG010111000± 32.9
OG011142000± 31.1
OG012226000± 46.3
OG013291000± 39.6
OG014457000± 23.3
OG015426000± 30.4
OG016770000± 59.0
OG0171110000± 21.4
OG0181730000± 28.7
OG0193110000± 17.5
OG0207700± 32.6
OG02119900± 87.1
OG02233800± 89.1
OG023137000± 41.4
OG024119000± 71.4
OG025147000± 25.9
OG026271000± 25
OG027248000± 57.6
OG028516000± 21.1
OG029832000± 11.4
OG030986000± 26.2
OG031137000± 7.7
OG0321740000± 50.3
OG0332130000± 27.5
Cycle 2
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
ParticipantsOG0041
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0071
ParticipantsOG0081
ParticipantsOG0094
ParticipantsOG0103
ParticipantsOG0112
ParticipantsOG0123
ParticipantsOG0133
ParticipantsOG0142
ParticipantsOG0152
ParticipantsOG0163
ParticipantsOG0172
ParticipantsOG0183
ParticipantsOG0192
ParticipantsOG0203
ParticipantsOG0213
ParticipantsOG0222
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0252
ParticipantsOG0263
ParticipantsOG0273
ParticipantsOG0283
ParticipantsOG0293
ParticipantsOG0303
ParticipantsOG0312
ParticipantsOG0322
ParticipantsOG03320
Title
Measurements
OG0000.141± NANA = %GCV values were not reported when n\<2.
OG003126± NANA = %GCV values were not reported when n\<2.
OG004118± NANA = %GCV values were not reported when n\<2.
OG005
Cycle 3
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0041
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0093
ParticipantsOG0103
ParticipantsOG0111
ParticipantsOG0123
ParticipantsOG0133
ParticipantsOG0143
ParticipantsOG0152
ParticipantsOG0163
ParticipantsOG0171
ParticipantsOG0181
ParticipantsOG0192
ParticipantsOG0203
ParticipantsOG0212
ParticipantsOG0221
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0252
ParticipantsOG0263
ParticipantsOG0273
ParticipantsOG0283
ParticipantsOG0293
ParticipantsOG0303
ParticipantsOG0311
ParticipantsOG0322
ParticipantsOG03318
Title
Measurements
OG0000.893± NANA = %GCV values were not reported when n\<2.
OG004135± NANA = %GCV values were not reported when n\<2.
OG008NA± NANA = AUC0-21 was not calculable.
OG009
Cycle 4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0102
ParticipantsOG0111
ParticipantsOG0122
ParticipantsOG0132
ParticipantsOG0142
ParticipantsOG0152
ParticipantsOG0161
ParticipantsOG0170
ParticipantsOG0181
ParticipantsOG0191
ParticipantsOG0201
ParticipantsOG0210
ParticipantsOG0221
ParticipantsOG0232
ParticipantsOG0241
ParticipantsOG0252
ParticipantsOG0260
ParticipantsOG0273
ParticipantsOG0281
ParticipantsOG0292
ParticipantsOG0301
ParticipantsOG0310
ParticipantsOG0321
ParticipantsOG03316
Title
Measurements
OG01018500± 8160.0
OG011250000± NANA = %GCV values were not reported when n\<2.
OG01280600± 247.9
OG013
1
OG0041
OG0051
OG0061
OG0071
OG0081
OG0096
OG0103
OG0113
OG0123
OG0133
OG0143
OG0155
OG0164
OG0173
OG0183
OG0193
OG0203
OG0214
OG0223
OG0233
OG0243
OG0253
OG0264
OG0273
OG0283
OG0293
OG0303
OG0313
OG0324
OG03323
1
ParticipantsOG0041
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0071
ParticipantsOG0081
ParticipantsOG0096
ParticipantsOG0103
ParticipantsOG0113
ParticipantsOG0123
ParticipantsOG0133
ParticipantsOG0143
ParticipantsOG0155
ParticipantsOG0164
ParticipantsOG0173
ParticipantsOG0183
ParticipantsOG0193
ParticipantsOG0203
ParticipantsOG0214
ParticipantsOG0223
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0253
ParticipantsOG0264
ParticipantsOG0273
ParticipantsOG0283
ParticipantsOG0293
ParticipantsOG0303
ParticipantsOG0313
ParticipantsOG0324
ParticipantsOG03323
Title
Measurements
OG0001.08± NANA = %GCV values were not reported when n\<2.
OG0013.89± NANA = %GCV values were not reported when n\<2.
OG00224.6± NANA = %GCV values were not reported when n\<2.
OG00339.0± NANA = %GCV values were not reported when n\<2.
OG00469.4± NANA = %GCV values were not reported when n\<2.
OG005672± NANA = %GCV values were not reported when n\<2.
OG0063010± NANA = %GCV values were not reported when n\<2.
OG0078300± NANA = %GCV values were not reported when n\<2.
OG00814300± NANA = %GCV values were not reported when n\<2.
OG00979500± 34.6
OG010111000± 32.7
OG011141000± 31.6
OG012226000± 46.4
OG013290000± 39.4
OG014451000± 23.9
OG015354000± 51.6
OG016677000± 82.2
OG0171170000± 31.1
OG0181720000± 29.0
OG0193310000± 17.1
OG0207700± 32.6
OG02114100± 57.6
OG02231900± 88.8
OG023137000± 41.5
OG024120000± 71.0
OG025142000± 31.9
OG026200000± 76.6
OG027248000± 57.5
OG028477000± 16.2
OG029830000± 11.3
OG030967000± 25.3
OG031738000± 141.5
OG0321280000± 126.2
OG0332140000± 27.5
Cycle 2
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
ParticipantsOG0041
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0071
ParticipantsOG0081
ParticipantsOG0094
ParticipantsOG0103
ParticipantsOG0112
ParticipantsOG0123
ParticipantsOG0133
ParticipantsOG0143
ParticipantsOG0152
ParticipantsOG0163
ParticipantsOG0173
ParticipantsOG0183
ParticipantsOG0193
ParticipantsOG0203
ParticipantsOG0213
ParticipantsOG0223
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0252
ParticipantsOG0263
ParticipantsOG0273
ParticipantsOG0283
ParticipantsOG0293
ParticipantsOG0303
ParticipantsOG0312
ParticipantsOG0322
ParticipantsOG03323
Title
Measurements
OG0000.0632± NANA = %GCV values were not reported when n\<2.
OG00386.9± NANA = %GCV values were not reported when n\<2.
OG004118± NANA = %GCV values were not reported when n\<2.
OG005
Cycle 3
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0041
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0094
ParticipantsOG0103
ParticipantsOG0112
ParticipantsOG0123
ParticipantsOG0133
ParticipantsOG0143
ParticipantsOG0152
ParticipantsOG0163
ParticipantsOG0171
ParticipantsOG0181
ParticipantsOG0193
ParticipantsOG0203
ParticipantsOG0213
ParticipantsOG0222
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0252
ParticipantsOG0263
ParticipantsOG0273
ParticipantsOG0283
ParticipantsOG0293
ParticipantsOG0303
ParticipantsOG0312
ParticipantsOG0322
ParticipantsOG03318
Title
Measurements
OG0000.879± NANA = %GCV values were not reported when n\<2.
OG004135± NANA = %GCV values were not reported when n\<2.
OG0087.48± NANA = %GCV values were not reported when n\<2.
OG009
Cycle 4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0102
ParticipantsOG0112
ParticipantsOG0122
ParticipantsOG0132
ParticipantsOG0142
ParticipantsOG0152
ParticipantsOG0162
ParticipantsOG0170
ParticipantsOG0181
ParticipantsOG0191
ParticipantsOG0201
ParticipantsOG0210
ParticipantsOG0221
ParticipantsOG0232
ParticipantsOG0242
ParticipantsOG0252
ParticipantsOG0260
ParticipantsOG0273
ParticipantsOG0281
ParticipantsOG0292
ParticipantsOG0301
ParticipantsOG0310
ParticipantsOG0322
ParticipantsOG03318
Title
Measurements
OG01011500± 4140.6
OG01114600± 18895.8
OG01261500± 136.5
OG013
1
OG0041
OG0051
OG0061
OG0071
OG0081
OG0096
OG0103
OG0113
OG0123
OG0133
OG0143
OG0155
OG0164
OG0173
OG0183
OG0193
OG0203
OG0214
OG0223
OG0233
OG0243
OG0253
OG0264
OG0273
OG0283
OG0293
OG0303
OG0313
OG0324
OG03323
1
ParticipantsOG0041
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0071
ParticipantsOG0081
ParticipantsOG0096
ParticipantsOG0103
ParticipantsOG0113
ParticipantsOG0123
ParticipantsOG0133
ParticipantsOG0143
ParticipantsOG0155
ParticipantsOG0164
ParticipantsOG0173
ParticipantsOG0183
ParticipantsOG0193
ParticipantsOG0203
ParticipantsOG0214
ParticipantsOG0223
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0253
ParticipantsOG0263
ParticipantsOG0273
ParticipantsOG0283
ParticipantsOG0293
ParticipantsOG0303
ParticipantsOG0312
ParticipantsOG0324
ParticipantsOG03323
Title
Measurements
OG0001.09± NANA = %GCV values were not reported when n\<2.
OG0013.92± NANA = %GCV values were not reported when n\<2.
OG00224.8± NANA = %GCV values were not reported when n\<2.
OG00339.3± NANA = %GCV values were not reported when n\<2.
OG00469.5± NANA = %GCV values were not reported when n\<2.
OG005673± NANA = %GCV values were not reported when n\<2.
OG0063190± NANA = %GCV values were not reported when n\<2.
OG0078420± NANA = %GCV values were not reported when n\<2.
OG00829400± NANA = %GCV values were not reported when n\<2.
OG009105000± 54
OG010141000± 55.5
OG011148000± 37.7
OG012333000± 59.5
OG013345000± 54.4
OG014558000± 31.1
OG015501000± 51.5
OG0161120000± 67.1
OG0171500000± 17.2
OG0182580000± 9.88
OG0194520000± 19.2
OG0207750± 32.8
OG02120600± 89.4
OG02240200± 121.9
OG023200000± 74.6
OG024142000± 90.1
OG025187000± 46.0
OG026336000± 23.4
OG027338000± 76.2
OG028730000± 15.9
OG0291240000± 12.4
OG0301300000± 52.3
OG0312090000± 26.2
OG0322340000± 77.0
OG0333200000± 43.0
Cycle 2
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
ParticipantsOG0041
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0071
ParticipantsOG0081
ParticipantsOG0094
ParticipantsOG0103
ParticipantsOG0112
ParticipantsOG0123
ParticipantsOG0133
ParticipantsOG0142
ParticipantsOG0152
ParticipantsOG0163
ParticipantsOG0172
ParticipantsOG0183
ParticipantsOG0192
ParticipantsOG0203
ParticipantsOG0213
ParticipantsOG0222
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0252
ParticipantsOG0263
ParticipantsOG0273
ParticipantsOG0283
ParticipantsOG0293
ParticipantsOG0303
ParticipantsOG0312
ParticipantsOG0322
ParticipantsOG03320
Title
Measurements
OG000NA± NANA = AUC0-inf was not calculable.
OG003126± NANA = %GCV values were not reported when n\<2.
OG004118± NANA = %GCV values were not reported when n\<2.
OG005
Cycle 3
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0041
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0093
ParticipantsOG0103
ParticipantsOG0111
ParticipantsOG0123
ParticipantsOG0133
ParticipantsOG0143
ParticipantsOG0152
ParticipantsOG0163
ParticipantsOG0171
ParticipantsOG0181
ParticipantsOG0192
ParticipantsOG0203
ParticipantsOG0212
ParticipantsOG0221
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0252
ParticipantsOG0263
ParticipantsOG0273
ParticipantsOG0283
ParticipantsOG0293
ParticipantsOG0303
ParticipantsOG0311
ParticipantsOG0322
ParticipantsOG03318
Title
Measurements
OG0000.896± NANA = %GCV values were not reported when n\<2.
OG004135± NANA = %GCV values were not reported when n\<2.
OG008NA± NANA = AUC0-inf was not calculable.
OG009
Cycle 4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0102
ParticipantsOG0111
ParticipantsOG0122
ParticipantsOG0132
ParticipantsOG0142
ParticipantsOG0152
ParticipantsOG0161
ParticipantsOG0170
ParticipantsOG0181
ParticipantsOG0191
ParticipantsOG0201
ParticipantsOG0210
ParticipantsOG0221
ParticipantsOG0232
ParticipantsOG0241
ParticipantsOG0252
ParticipantsOG0260
ParticipantsOG0273
ParticipantsOG0281
ParticipantsOG0292
ParticipantsOG0301
ParticipantsOG0310
ParticipantsOG0321
ParticipantsOG03316
Title
Measurements
OG01018200± 20134.8
OG011309000± NANA = %GCV values were not reported when n\<2.
OG01285500± 284.2
OG013
1
OG0041
OG0051
OG0061
OG0071
OG0081
OG0096
OG0103
OG0113
OG0123
OG0133
OG0143
OG0155
OG0164
OG0173
OG0183
OG0193
OG0203
OG0214
OG0223
OG0233
OG0243
OG0253
OG0264
OG0273
OG0283
OG0293
OG0303
OG0313
OG0324
OG03323
1
ParticipantsOG0041
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0071
ParticipantsOG0081
ParticipantsOG0096
ParticipantsOG0103
ParticipantsOG0113
ParticipantsOG0123
ParticipantsOG0133
ParticipantsOG0143
ParticipantsOG0155
ParticipantsOG0164
ParticipantsOG0173
ParticipantsOG0183
ParticipantsOG0193
ParticipantsOG0203
ParticipantsOG0214
ParticipantsOG0223
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0253
ParticipantsOG0263
ParticipantsOG0273
ParticipantsOG0283
ParticipantsOG0293
ParticipantsOG0303
ParticipantsOG0312
ParticipantsOG0324
ParticipantsOG03323
Title
Measurements
OG0001.38± NANA = %GCV values were not reported when n\<2.
OG0011.15± NANA = %GCV values were not reported when n\<2.
OG0020.565± NANA = %GCV values were not reported when n\<2.
OG0031.02± NANA = %GCV values were not reported when n\<2.
OG0041.73± NANA = %GCV values were not reported when n\<2.
OG0050.550± NANA = %GCV values were not reported when n\<2.
OG0060.344± NANA = %GCV values were not reported when n\<2.
OG0070.392± NANA = %GCV values were not reported when n\<2.
OG0080.341± NANA = %GCV values were not reported when n\<2.
OG0090.286± 54.0
OG0100.299± 55.5
OG0110.400± 37.7
OG0120.246± 59.5
OG0130.348± 54.4
OG0140.305± 31.1
OG0150.479± 51.5
OG0160.304± 67.1
OG0170.320± 17.2
OG0180.259± 9.9
OG0190.199± 19.2
OG0200.142± 32.8
OG0210.161± 89.4
OG0220.249± 122
OG0230.150± 74.4
OG0240.296± 90.1
OG0250.315± 46.0
OG0260.244± 23.4
OG0270.302± 51.3
OG0280.233± 15.9
OG0290.193± 12.4
OG0300.262± 52.3
OG0310.230± 26.2
OG0320.287± 77.0
OG0330.279± 40.9
Cycle 2
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
ParticipantsOG0041
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0071
ParticipantsOG0081
ParticipantsOG0094
ParticipantsOG0103
ParticipantsOG0112
ParticipantsOG0123
ParticipantsOG0133
ParticipantsOG0142
ParticipantsOG0152
ParticipantsOG0163
ParticipantsOG0172
ParticipantsOG0183
ParticipantsOG0192
ParticipantsOG0203
ParticipantsOG0213
ParticipantsOG0222
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0252
ParticipantsOG0263
ParticipantsOG0273
ParticipantsOG0283
ParticipantsOG0293
ParticipantsOG0303
ParticipantsOG0312
ParticipantsOG0322
ParticipantsOG03320
Title
Measurements
OG00010.6± NANA = %GCV values were not reported when n\<2.
OG0030.319± NANA = %GCV values were not reported when n\<2.
OG0041.02± NANA = %GCV values were not reported when n\<2.
OG005
Cycle 3
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0041
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0093
ParticipantsOG0103
ParticipantsOG0111
ParticipantsOG0123
ParticipantsOG0133
ParticipantsOG0143
ParticipantsOG0152
ParticipantsOG0163
ParticipantsOG0171
ParticipantsOG0181
ParticipantsOG0192
ParticipantsOG0203
ParticipantsOG0212
ParticipantsOG0221
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0252
ParticipantsOG0263
ParticipantsOG0273
ParticipantsOG0283
ParticipantsOG0293
ParticipantsOG0303
ParticipantsOG0311
ParticipantsOG0322
ParticipantsOG03318
Title
Measurements
OG0001.68± NANA = %GCV values were not reported when n\<2.
OG0040.887± NANA = %GCV values were not reported when n\<2.
OG008NA± NANA = CL was not calculable.
OG009
Cycle 4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0102
ParticipantsOG0111
ParticipantsOG0122
ParticipantsOG0132
ParticipantsOG0142
ParticipantsOG0152
ParticipantsOG0161
ParticipantsOG0170
ParticipantsOG0181
ParticipantsOG0191
ParticipantsOG0201
ParticipantsOG0210
ParticipantsOG0221
ParticipantsOG0232
ParticipantsOG0241
ParticipantsOG0252
ParticipantsOG0260
ParticipantsOG0273
ParticipantsOG0281
ParticipantsOG0292
ParticipantsOG0301
ParticipantsOG0310
ParticipantsOG0321
ParticipantsOG03316
Title
Measurements
OG0102.27± 8160.0
OG0110.236± NANA = %GCV values were not reported when n\<2.
OG0121.02± 247.9
OG013
1
OG0041
OG0051
OG0061
OG0071
OG0081
OG0096
OG0103
OG0113
OG0123
OG0133
OG0143
OG0155
OG0164
OG0173
OG0183
OG0193
OG0203
OG0214
OG0223
OG0233
OG0243
OG0253
OG0264
OG0273
OG0283
OG0293
OG0303
OG0313
OG0324
OG03323
1
ParticipantsOG0041
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0071
ParticipantsOG0081
ParticipantsOG0096
ParticipantsOG0103
ParticipantsOG0113
ParticipantsOG0123
ParticipantsOG0133
ParticipantsOG0143
ParticipantsOG0155
ParticipantsOG0164
ParticipantsOG0173
ParticipantsOG0183
ParticipantsOG0193
ParticipantsOG0203
ParticipantsOG0214
ParticipantsOG0223
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0253
ParticipantsOG0263
ParticipantsOG0273
ParticipantsOG0283
ParticipantsOG0293
ParticipantsOG0303
ParticipantsOG0312
ParticipantsOG0324
ParticipantsOG03323
Title
Measurements
OG0005.19± NANA = %GCV values were not reported when n\<2.
OG0014.55± NANA = %GCV values were not reported when n\<2.
OG0022.18± NANA = %GCV values were not reported when n\<2.
OG0035.11± NANA = %GCV values were not reported when n\<2.
OG0046.80± NANA = %GCV values were not reported when n\<2.
OG0051.67± NANA = %GCV values were not reported when n\<2.
OG0061.68± NANA = %GCV values were not reported when n\<2.
OG0071.87± NANA = %GCV values were not reported when n\<2.
OG0083.74± NANA = %GCV values were not reported when n\<2.
OG0093.20± 32.6
OG0103.23± 48.9
OG0111.69± 49.7
OG0124.56± 35.4
OG0133.19± 69.7
OG0143.37± 19.3
OG0153.57± 79.9
OG0165.27± 67.9
OG0175.21± 34.4
OG0184.92± 48.4
OG0193.54± 17.1
OG0200.587± 30.2
OG0210.844± 55.6
OG0222.21± 33.9
OG0232.61± 10.8
OG0243.12± 46.6
OG0253.91± 22.6
OG0263.11± 28.8
OG0274.73± 21.2
OG0284.01± 27.1
OG0293.62± 14.0
OG0302.95± 48.8
OG0314.44± 10.4
OG0323.74± 1.0
OG0334.85± 38.1
Cycle 2
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
ParticipantsOG0041
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0071
ParticipantsOG0081
ParticipantsOG0094
ParticipantsOG0103
ParticipantsOG0111
ParticipantsOG0123
ParticipantsOG0133
ParticipantsOG0142
ParticipantsOG0152
ParticipantsOG0163
ParticipantsOG0172
ParticipantsOG0183
ParticipantsOG0192
ParticipantsOG0203
ParticipantsOG0213
ParticipantsOG0222
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0252
ParticipantsOG0263
ParticipantsOG0273
ParticipantsOG0283
ParticipantsOG0293
ParticipantsOG0303
ParticipantsOG0312
ParticipantsOG0322
ParticipantsOG03320
Title
Measurements
OG000NA± NANA = V was not calculable.
OG0031.10± NANA = %GCV values were not reported when n\<2.
OG0042.49± NANA = %GCV values were not reported when n\<2.
OG005
Cycle 3
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0041
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0093
ParticipantsOG0103
ParticipantsOG0111
ParticipantsOG0123
ParticipantsOG0133
ParticipantsOG0142
ParticipantsOG0152
ParticipantsOG0163
ParticipantsOG0171
ParticipantsOG0181
ParticipantsOG0192
ParticipantsOG0202
ParticipantsOG0212
ParticipantsOG0221
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0252
ParticipantsOG0263
ParticipantsOG0273
ParticipantsOG0283
ParticipantsOG0293
ParticipantsOG0303
ParticipantsOG0311
ParticipantsOG0322
ParticipantsOG03318
Title
Measurements
OG0003.58± NANA = %GCV values were not reported when n\<2.
OG0041.99± NANA = %GCV values were not reported when n\<2.
OG008NA± NANA = V was not calculable.
OG009
Cycle 4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0101
ParticipantsOG0111
ParticipantsOG0122
ParticipantsOG0132
ParticipantsOG0142
ParticipantsOG0152
ParticipantsOG0161
ParticipantsOG0170
ParticipantsOG0181
ParticipantsOG0191
ParticipantsOG0201
ParticipantsOG0210
ParticipantsOG0221
ParticipantsOG0232
ParticipantsOG0241
ParticipantsOG0252
ParticipantsOG0260
ParticipantsOG0273
ParticipantsOG0281
ParticipantsOG0292
ParticipantsOG0301
ParticipantsOG0310
ParticipantsOG0321
ParticipantsOG03316
Title
Measurements
OG0103.32± NANA = %GCV values were not reported when n\<2.
OG0113.00± NANA = %GCV values were not reported when n\<2.
OG0124.03± 16.5
OG013
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG0140
OG0150
OG0160
OG0170
OG0180
OG0190
OG0203
OG0214
OG0223
OG0233
OG0243
OG0253
OG0264
OG0273
OG0283
OG0293
OG0303
OG0313
OG0324
OG03323
0
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0190
ParticipantsOG0203
ParticipantsOG0214
ParticipantsOG0223
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0253
ParticipantsOG0264
ParticipantsOG0273
ParticipantsOG0283
ParticipantsOG0292
ParticipantsOG0303
ParticipantsOG0313
ParticipantsOG0324
ParticipantsOG03323
Title
Measurements
OG02082400± 27.9
OG02168500± 32.4
OG02251700± 25.7
OG02381700± 17.2
OG02457600± 35.7
OG02578400± 18.4
OG02672600± 24.3
OG02757700± 27.2
OG02863300± 30.7
OG02983700± 24.8
OG03066900± 4.1
OG03181600± 22.5
OG03270400± 15.1
OG03369900± 20.9
Cycle 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0190
ParticipantsOG0203
ParticipantsOG0213
ParticipantsOG0223
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0252
ParticipantsOG0263
ParticipantsOG0273
ParticipantsOG0282
ParticipantsOG0292
ParticipantsOG0303
ParticipantsOG0312
ParticipantsOG0322
ParticipantsOG03323
Title
Measurements
OG02090000± 32.2
OG02176800± 31.8
OG02261300± 17.2
OG023
Cycle 3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0190
ParticipantsOG0203
ParticipantsOG0213
ParticipantsOG0222
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0252
ParticipantsOG0263
ParticipantsOG0272
ParticipantsOG0282
ParticipantsOG0293
ParticipantsOG0303
ParticipantsOG0312
ParticipantsOG0322
ParticipantsOG03318
Title
Measurements
OG02097200± 56.3
OG02178400± 31.7
OG02261600± 22.9
OG023
Cycle 4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0190
ParticipantsOG0201
ParticipantsOG0211
ParticipantsOG0221
ParticipantsOG0232
ParticipantsOG0242
ParticipantsOG0252
ParticipantsOG0260
ParticipantsOG0272
ParticipantsOG0280
ParticipantsOG0292
ParticipantsOG0301
ParticipantsOG0310
ParticipantsOG0322
ParticipantsOG03318
Title
Measurements
OG020156000± NANA = %GCV values were not reported when n\<2.
OG02154700± NANA = %GCV values were not reported when n\<2.
OG02257000± NANA = %GCV values were not reported when n\<2.
OG023
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG0140
OG0150
OG0160
OG0170
OG0180
OG0190
OG0203
OG0214
OG0223
OG0233
OG0243
OG0253
OG0264
OG0273
OG0283
OG0293
OG0303
OG0313
OG0324
OG03323
0
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0190
ParticipantsOG0203
ParticipantsOG0214
ParticipantsOG0223
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0253
ParticipantsOG0264
ParticipantsOG0273
ParticipantsOG0283
ParticipantsOG0292
ParticipantsOG0303
ParticipantsOG0313
ParticipantsOG0324
ParticipantsOG03323
Title
Measurements
OG0200.03(0.03 to 0.15)
OG0210.06(0.03 to 0.13)
OG0220.02(0.02 to 0.03)
OG0230.08(0.02 to 0.09)
OG0240.02(0.02 to 0.03)
OG0250.03(0.02 to 0.07)
OG0260.06(0.02 to 0.13)
OG0270.04(0.02 to 0.13)
OG0280.02(0.02 to 0.03)
OG0290.11(0.08 to 0.14)
OG0300.07(0.02 to 0.13)
OG0310.02(0.02 to 0.06)
OG0320.05(0.02 to 0.13)
OG0330.02(0.02 to 13.97)
Cycle 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0190
ParticipantsOG0203
ParticipantsOG0213
ParticipantsOG0223
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0252
ParticipantsOG0263
ParticipantsOG0273
ParticipantsOG0282
ParticipantsOG0292
ParticipantsOG0303
ParticipantsOG0312
ParticipantsOG0322
ParticipantsOG03323
Title
Measurements
OG0200.03(0.02 to 0.07)
OG0210.03(0.03 to 0.03)
OG0220.03(0.02 to 0.07)
OG023
Cycle 3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0190
ParticipantsOG0203
ParticipantsOG0213
ParticipantsOG0222
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0252
ParticipantsOG0263
ParticipantsOG0272
ParticipantsOG0282
ParticipantsOG0293
ParticipantsOG0303
ParticipantsOG0312
ParticipantsOG0322
ParticipantsOG03318
Title
Measurements
OG0200.03(0.03 to 0.13)
OG0210.03(0.03 to 0.03)
OG0220.03(0.02 to 0.03)
OG023
Cycle 4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0190
ParticipantsOG0201
ParticipantsOG0211
ParticipantsOG0221
ParticipantsOG0232
ParticipantsOG0242
ParticipantsOG0252
ParticipantsOG0260
ParticipantsOG0272
ParticipantsOG0280
ParticipantsOG0292
ParticipantsOG0301
ParticipantsOG0310
ParticipantsOG0322
ParticipantsOG03318
Title
Measurements
OG0200.13(0.13 to 0.13)
OG0210.08(0.08 to 0.08)
OG0220.04(0.04 to 0.04)
OG023
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG0140
OG0150
OG0160
OG0170
OG0180
OG0190
OG0203
OG0214
OG0223
OG0233
OG0243
OG0253
OG0264
OG0273
OG0283
OG0293
OG0303
OG0313
OG0324
OG03323
0
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0190
ParticipantsOG0203
ParticipantsOG0214
ParticipantsOG0223
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0253
ParticipantsOG0264
ParticipantsOG0273
ParticipantsOG0283
ParticipantsOG0292
ParticipantsOG0302
ParticipantsOG0313
ParticipantsOG0324
ParticipantsOG03322
Title
Measurements
OG02017.2± 21.8
OG02112.1± 80.3
OG02214.7± 32.7
OG02323.5± 54.4
OG02411.8± 46.4
OG0259.45± 61.8
OG02610.9± 43.5
OG02717.7± 23.1
OG02811.3± 22.9
OG02916.1± 27.6
OG03013.2± 63.6
OG0318.84± 189.6
OG03211.2± 64.2
OG03319.0± 54.1
Cycle 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0190
ParticipantsOG0203
ParticipantsOG0213
ParticipantsOG0223
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0252
ParticipantsOG0263
ParticipantsOG0272
ParticipantsOG0282
ParticipantsOG0292
ParticipantsOG0303
ParticipantsOG0312
ParticipantsOG0322
ParticipantsOG03319
Title
Measurements
OG02016.8± 30.6
OG02121.1± 22.4
OG02210± 189.6
OG023
Cycle 3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0190
ParticipantsOG0203
ParticipantsOG0213
ParticipantsOG0222
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0252
ParticipantsOG0263
ParticipantsOG0272
ParticipantsOG0282
ParticipantsOG0291
ParticipantsOG0303
ParticipantsOG0312
ParticipantsOG0322
ParticipantsOG03318
Title
Measurements
OG02014.0± 59.2
OG02110.5± 42.1
OG02214.6± 39.4
OG023
Cycle 4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0190
ParticipantsOG0201
ParticipantsOG0211
ParticipantsOG0221
ParticipantsOG0232
ParticipantsOG0241
ParticipantsOG0251
ParticipantsOG0260
ParticipantsOG0272
ParticipantsOG0280
ParticipantsOG0291
ParticipantsOG0301
ParticipantsOG0310
ParticipantsOG0322
ParticipantsOG03318
Title
Measurements
OG02017.7± NANA = %GCV values were not reported when n\<2.
OG02111.1± NANA = %GCV values were not reported when n\<2.
OG02210.5± NANA = %GCV values were not reported when n\<2.
OG023
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG0140
OG0150
OG0160
OG0170
OG0180
OG0190
OG0203
OG0214
OG0223
OG0233
OG0243
OG0253
OG0264
OG0273
OG0283
OG0293
OG0303
OG0313
OG0324
OG03323
0
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0190
ParticipantsOG0203
ParticipantsOG0214
ParticipantsOG0223
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0253
ParticipantsOG0264
ParticipantsOG0273
ParticipantsOG0283
ParticipantsOG0292
ParticipantsOG0302
ParticipantsOG0313
ParticipantsOG0324
ParticipantsOG03322
Title
Measurements
OG020587000± 36.0
OG021484000± 33.8
OG022408000± 10.7
OG023664000± 15.8
OG024404000± 46.4
OG025511000± 32.3
OG026535000± 31.1
OG027454000± 26.0
OG028516000± 29.0
OG029664000± 9.7
OG030560000± 26.5
OG031485000± 92.9
OG032599000± 34.6
OG033619000± 33.9
Cycle 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0190
ParticipantsOG0203
ParticipantsOG0213
ParticipantsOG0223
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0252
ParticipantsOG0263
ParticipantsOG0272
ParticipantsOG0282
ParticipantsOG0292
ParticipantsOG0303
ParticipantsOG0312
ParticipantsOG0322
ParticipantsOG03319
Title
Measurements
OG020847000± 33.5
OG021672000± 45.4
OG022405000± 62.8
OG023
Cycle 3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0190
ParticipantsOG0203
ParticipantsOG0213
ParticipantsOG0222
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0252
ParticipantsOG0263
ParticipantsOG0272
ParticipantsOG0282
ParticipantsOG0291
ParticipantsOG0303
ParticipantsOG0312
ParticipantsOG0322
ParticipantsOG03318
Title
Measurements
OG020913000± 53.8
OG021662000± 38.5
OG022622000± 2.3
OG023
Cycle 4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0190
ParticipantsOG0201
ParticipantsOG0211
ParticipantsOG0221
ParticipantsOG0232
ParticipantsOG0241
ParticipantsOG0252
ParticipantsOG0260
ParticipantsOG0272
ParticipantsOG0280
ParticipantsOG0291
ParticipantsOG0301
ParticipantsOG0310
ParticipantsOG0322
ParticipantsOG03318
Title
Measurements
OG0201540000± NANA = %GCV values were not reported when n\<2.
OG021490000± NANA = %GCV values were not reported when n\<2.
OG022613000± NANA = %GCV values were not reported when n\<2.
OG023
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG0140
OG0150
OG0160
OG0170
OG0180
OG0190
OG0203
OG0214
OG0223
OG0233
OG0243
OG0253
OG0264
OG0273
OG0283
OG0293
OG0303
OG0313
OG0324
OG03323
0
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0190
ParticipantsOG0203
ParticipantsOG0214
ParticipantsOG0223
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0253
ParticipantsOG0264
ParticipantsOG0273
ParticipantsOG0283
ParticipantsOG0292
ParticipantsOG0303
ParticipantsOG0313
ParticipantsOG0324
ParticipantsOG03322
Title
Measurements
OG020587000± 36.0
OG021356000± 79.5
OG022398000± 14.3
OG023663000± 16.1
OG024410000± 44.5
OG025491000± 39.9
OG026482000± 48.7
OG027414000± 35.3
OG028415000± 73.7
OG029663000± 9.5
OG030549000± 18.7
OG031389000± 162.2
OG032416000± 119.9
OG033624000± 34.3
Cycle 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0190
ParticipantsOG0203
ParticipantsOG0213
ParticipantsOG0223
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0252
ParticipantsOG0263
ParticipantsOG0273
ParticipantsOG0282
ParticipantsOG0292
ParticipantsOG0303
ParticipantsOG0312
ParticipantsOG0322
ParticipantsOG03323
Title
Measurements
OG020847000± 33.4
OG021664000± 45.0
OG022321000± 125.7
OG023
Cycle 3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0190
ParticipantsOG0203
ParticipantsOG0213
ParticipantsOG0222
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0252
ParticipantsOG0263
ParticipantsOG0272
ParticipantsOG0282
ParticipantsOG0293
ParticipantsOG0303
ParticipantsOG0312
ParticipantsOG0322
ParticipantsOG03318
Title
Measurements
OG020466000± 258.9
OG021515000± 43.0
OG022554000± 14.0
OG023
Cycle 4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0190
ParticipantsOG0201
ParticipantsOG0211
ParticipantsOG0221
ParticipantsOG0232
ParticipantsOG0241
ParticipantsOG0252
ParticipantsOG0260
ParticipantsOG0272
ParticipantsOG0280
ParticipantsOG0292
ParticipantsOG0301
ParticipantsOG0310
ParticipantsOG0322
ParticipantsOG03318
Title
Measurements
OG0201550000± NANA = %GCV values were not reported when n\<2.
OG021490000± NANA = %GCV values were not reported when n\<2.
OG022304000± NANA = %GCV values were not reported when n\<2.
OG023
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG0140
OG0150
OG0160
OG0170
OG0180
OG0190
OG0203
OG0214
OG0223
OG0233
OG0243
OG0253
OG0264
OG0273
OG0283
OG0293
OG0303
OG0313
OG0324
OG03323
0
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0190
ParticipantsOG0203
ParticipantsOG0214
ParticipantsOG0223
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0253
ParticipantsOG0264
ParticipantsOG0273
ParticipantsOG0283
ParticipantsOG0292
ParticipantsOG0302
ParticipantsOG0313
ParticipantsOG0324
ParticipantsOG03322
Title
Measurements
OG020985000± 28.0
OG021709000± 46.3
OG022647000± 11.8
OG0231400000± 15.6
OG024582000± 65.7
OG025666000± 54.4
OG026740000± 39.0
OG027786000± 37.5
OG028703000± 36.0
OG0291090000± 23.0
OG030858000± 58.4
OG031707000± 148.2
OG032855000± 55.9
OG0331130000± 68.7
Cycle 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0190
ParticipantsOG0203
ParticipantsOG0213
ParticipantsOG0223
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0252
ParticipantsOG0263
ParticipantsOG0272
ParticipantsOG0282
ParticipantsOG0292
ParticipantsOG0303
ParticipantsOG0312
ParticipantsOG0322
ParticipantsOG03319
Title
Measurements
OG0201450000± 51.4
OG0211280000± 47.7
OG022655000± 104.6
OG023
Cycle 3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0190
ParticipantsOG0203
ParticipantsOG0213
ParticipantsOG0222
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0252
ParticipantsOG0263
ParticipantsOG0272
ParticipantsOG0282
ParticipantsOG0291
ParticipantsOG0303
ParticipantsOG0312
ParticipantsOG0322
ParticipantsOG03318
Title
Measurements
OG0201440000± 94.2
OG021890000± 44.1
OG0221000000± 21.1
OG023
Cycle 4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0190
ParticipantsOG0201
ParticipantsOG0211
ParticipantsOG0221
ParticipantsOG0232
ParticipantsOG0241
ParticipantsOG0251
ParticipantsOG0260
ParticipantsOG0272
ParticipantsOG0280
ParticipantsOG0291
ParticipantsOG0301
ParticipantsOG0310
ParticipantsOG0322
ParticipantsOG03318
Title
Measurements
OG0202670000± NANA = %GCV values were not reported when n\<2.
OG021667000± NANA = %GCV values were not reported when n\<2.
OG022816000± NANA = %GCV values were not reported when n\<2.
OG023
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG0140
OG0150
OG0160
OG0170
OG0180
OG0190
OG0203
OG0214
OG0223
OG0233
OG0243
OG0253
OG0264
OG0273
OG0283
OG0293
OG0303
OG0313
OG0324
OG03323
0
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0190
ParticipantsOG0203
ParticipantsOG0214
ParticipantsOG0223
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0253
ParticipantsOG0264
ParticipantsOG0273
ParticipantsOG0283
ParticipantsOG0292
ParticipantsOG0302
ParticipantsOG0313
ParticipantsOG0324
ParticipantsOG03322
Title
Measurements
OG0200.203± 28.0
OG0210.282± 46.3
OG0220.309± 11.8
OG0230.143± 15.6
OG0240.344± 65.7
OG0250.301± 54.4
OG0260.270± 39.0
OG0270.255± 37.6
OG0280.284± 36.0
OG0290.184± 22.9
OG0300.233± 58.3
OG0310.283± 148.4
OG0320.234± 55.9
OG0330.176± 68.7
Cycle 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0190
ParticipantsOG0203
ParticipantsOG0213
ParticipantsOG0223
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0252
ParticipantsOG0263
ParticipantsOG0272
ParticipantsOG0282
ParticipantsOG0292
ParticipantsOG0303
ParticipantsOG0312
ParticipantsOG0322
ParticipantsOG03319
Title
Measurements
OG0200.236± 33.5
OG0210.298± 45.4
OG0220.494± 62.7
OG023
Cycle 3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0190
ParticipantsOG0203
ParticipantsOG0213
ParticipantsOG0222
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0252
ParticipantsOG0263
ParticipantsOG0272
ParticipantsOG0282
ParticipantsOG0291
ParticipantsOG0303
ParticipantsOG0312
ParticipantsOG0322
ParticipantsOG03318
Title
Measurements
OG0200.219± 53.8
OG0210.302± 38.5
OG0220.322± 2.3
OG023
Cycle 4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0190
ParticipantsOG0201
ParticipantsOG0211
ParticipantsOG0221
ParticipantsOG0232
ParticipantsOG0241
ParticipantsOG0252
ParticipantsOG0260
ParticipantsOG0272
ParticipantsOG0280
ParticipantsOG0291
ParticipantsOG0301
ParticipantsOG0310
ParticipantsOG0322
ParticipantsOG03318
Title
Measurements
OG0200.130± NANA = %GCV values were not reported when n\<2.
OG0210.408± NANA = %GCV values were not reported when n\<2.
OG0220.326± NANA = %GCV values were not reported when n\<2.
OG023
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG0140
OG0150
OG0160
OG0170
OG0180
OG0190
OG0203
OG0214
OG0223
OG0233
OG0243
OG0253
OG0264
OG0273
OG0283
OG0293
OG0303
OG0313
OG0324
OG03323
0
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0190
ParticipantsOG0203
ParticipantsOG0214
ParticipantsOG0223
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0253
ParticipantsOG0264
ParticipantsOG0273
ParticipantsOG0283
ParticipantsOG0292
ParticipantsOG0302
ParticipantsOG0313
ParticipantsOG0324
ParticipantsOG03322
Title
Measurements
OG0205.03± 46.6
OG0214.92± 60.7
OG0226.55± 21.6
OG0234.85± 37.3
OG0245.84± 28.1
OG0254.10± 6.1
OG0264.25± 37.9
OG0276.50± 19.5
OG0284.62± 23.8
OG0294.27± 4.5
OG0304.43± 4.2
OG0313.61± 30.0
OG0323.78± 16.7
OG0334.84± 32.3
Cycle 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0190
ParticipantsOG0203
ParticipantsOG0213
ParticipantsOG0223
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0252
ParticipantsOG0263
ParticipantsOG0272
ParticipantsOG0282
ParticipantsOG0292
ParticipantsOG0303
ParticipantsOG0312
ParticipantsOG0322
ParticipantsOG03319
Title
Measurements
OG0205.52± 17.2
OG0218.13± 53.3
OG0227.76± 54.5
OG023
Cycle 3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0190
ParticipantsOG0203
ParticipantsOG0213
ParticipantsOG0222
ParticipantsOG0233
ParticipantsOG0243
ParticipantsOG0252
ParticipantsOG0263
ParticipantsOG0272
ParticipantsOG0282
ParticipantsOG0291
ParticipantsOG0303
ParticipantsOG0312
ParticipantsOG0322
ParticipantsOG03318
Title
Measurements
OG0204.31± 10.4
OG0214.40± 50.6
OG0226.81± 44.4
OG023
Cycle 4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0190
ParticipantsOG0201
ParticipantsOG0211
ParticipantsOG0221
ParticipantsOG0232
ParticipantsOG0241
ParticipantsOG0251
ParticipantsOG0260
ParticipantsOG0272
ParticipantsOG0280
ParticipantsOG0291
ParticipantsOG0301
ParticipantsOG0310
ParticipantsOG0322
ParticipantsOG03318
Title
Measurements
OG0203.10± NANA = %GCV values were not reported when n\<2.
OG0216.37± NANA = %GCV values were not reported when n\<2.
OG0224.92± NANA = %GCV values were not reported when n\<2.
OG023
1
OG0041
OG0051
OG0061
OG0070
OG0081
OG0095
OG0103
OG0113
OG0123
OG0133
OG0143
OG0155
OG0163
OG0173
OG0181
OG0193
OG0203
OG0214
OG0223
OG0233
OG0243
OG0253
OG0263
OG0272
OG0283
OG0293
OG0303
OG0313
OG0323
OG03320
1
ParticipantsOG0041
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0095
ParticipantsOG0103
ParticipantsOG0113
ParticipantsOG0123
ParticipantsOG0132
ParticipantsOG0143
ParticipantsOG0154
ParticipantsOG0163
ParticipantsOG0173
ParticipantsOG0181
ParticipantsOG0193
ParticipantsOG0203
ParticipantsOG0214
ParticipantsOG0223
ParticipantsOG0232
ParticipantsOG0243
ParticipantsOG0253
ParticipantsOG0263
ParticipantsOG0270
ParticipantsOG0283
ParticipantsOG0293
ParticipantsOG0303
ParticipantsOG0313
ParticipantsOG0323
ParticipantsOG03320
Title
Measurements
OG000103.7± NANA = SD values were not reported when n\<2.
OG00252.8± NANA = SD values were not reported when n\<2.
OG00392.5± NANA = SD values were not reported when n\<2.
OG00451.9± NANA = SD values were not reported when n\<2.
OG0058.8± NANA = SD values were not reported when n\<2.
OG0064.6± NANA = SD values were not reported when n\<2.
OG0083.0± NANA = SD values were not reported when n\<2.
OG00926.3± 32.0
OG01010.8± 9.9
OG0119.1± 3.2
OG0124.2± 2.7
OG01341.9± 4.7
OG0147.4± 5.9
OG0159.5± 6.5
OG01613.9± 3.4
OG01715.0± 9.8
OG01826.0± NANA = SD values were not reported when n\<2.
OG01914.4± 15.1
OG0206.9± 3.2
OG0214.2± 1.5
OG0227.3± 3.6
OG0237.6± 6.8
OG0247.0± 2.6
OG0254.6± 2.3
OG02619.9± 15.4
OG02846.5± 54.5
OG0298.8± 5.3
OG03026.8± 18.4
OG03128.4± 28.3
OG03210.5± 8.9
OG03313.3± 17.4
Cycle 1:Day 1; 2 hours Post Infusion
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0031
ParticipantsOG0041
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0091
ParticipantsOG0100
ParticipantsOG0111
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0190
ParticipantsOG0203
ParticipantsOG0214
ParticipantsOG0223
ParticipantsOG0231
ParticipantsOG0240
ParticipantsOG0250
ParticipantsOG0260
ParticipantsOG0270
ParticipantsOG0280
ParticipantsOG0290
ParticipantsOG0300
ParticipantsOG0310
ParticipantsOG0320
ParticipantsOG0330
Title
Measurements
OG000102.5± NANA = SD values were not reported when n\<2.
OG00263.2± NANA = SD values were not reported when n\<2.
OG00391.7± NANA = SD values were not reported when n\<2.
OG004
Cycle 1: Day 2
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0031
ParticipantsOG0041
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0095
ParticipantsOG0102
ParticipantsOG0113
ParticipantsOG0123
ParticipantsOG0133
ParticipantsOG0143
ParticipantsOG0155
ParticipantsOG0163
ParticipantsOG0173
ParticipantsOG0181
ParticipantsOG0193
ParticipantsOG0203
ParticipantsOG0214
ParticipantsOG0222
ParticipantsOG0233
ParticipantsOG0242
ParticipantsOG0253
ParticipantsOG0262
ParticipantsOG0270
ParticipantsOG0282
ParticipantsOG0293
ParticipantsOG0302
ParticipantsOG0313
ParticipantsOG0321
ParticipantsOG03320
Title
Measurements
OG000107.0± NANA = SD values were not reported when n\<2.
OG00259.5± NANA = SD values were not reported when n\<2.
OG00396.9± NANA = SD values were not reported when n\<2.
OG004
Cycle 1: Day 3
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0031
ParticipantsOG0041
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0094
ParticipantsOG0100
ParticipantsOG0111
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0190
ParticipantsOG0203
ParticipantsOG0214
ParticipantsOG0223
ParticipantsOG0231
ParticipantsOG0240
ParticipantsOG0250
ParticipantsOG0260
ParticipantsOG0270
ParticipantsOG0280
ParticipantsOG0290
ParticipantsOG0300
ParticipantsOG0311
ParticipantsOG0320
ParticipantsOG0330
Title
Measurements
OG000109.1± NANA = SD values were not reported when n\<2.
OG002108.3± NANA = SD values were not reported when n\<2.
OG00385.4± NANA = SD values were not reported when n\<2.
OG004
Cycle 1: Day 5
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0031
ParticipantsOG0041
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0190
ParticipantsOG0200
ParticipantsOG0210
ParticipantsOG0220
ParticipantsOG0230
ParticipantsOG0240
ParticipantsOG0250
ParticipantsOG0260
ParticipantsOG0270
ParticipantsOG0280
ParticipantsOG0290
ParticipantsOG0300
ParticipantsOG0310
ParticipantsOG0320
ParticipantsOG0330
Title
Measurements
OG00097.5± NANA = SD values were not reported when n\<2.
OG002107.1± NANA = SD values were not reported when n\<2.
OG003111.6± NANA = SD values were not reported when n\<2.
OG004
Cycle 1: Day 8
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0031
ParticipantsOG0041
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0095
ParticipantsOG0103
ParticipantsOG0113
ParticipantsOG0123
ParticipantsOG0132
ParticipantsOG0143
ParticipantsOG0154
ParticipantsOG0163
ParticipantsOG0173
ParticipantsOG0181
ParticipantsOG0193
ParticipantsOG0203
ParticipantsOG0213
ParticipantsOG0223
ParticipantsOG0233
ParticipantsOG0242
ParticipantsOG0253
ParticipantsOG0263
ParticipantsOG0271
ParticipantsOG0281
ParticipantsOG0293
ParticipantsOG0302
ParticipantsOG0312
ParticipantsOG0321
ParticipantsOG03318
Title
Measurements
OG000100.2± NANA = SD values were not reported when n\<2.
OG002103.4± NANA = SD values were not reported when n\<2.
OG003114.9± NANA = SD values were not reported when n\<2.
OG004
Cycle 1: Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0031
ParticipantsOG0041
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0095
ParticipantsOG0102
ParticipantsOG0111
ParticipantsOG0122
ParticipantsOG0131
ParticipantsOG0143
ParticipantsOG0153
ParticipantsOG0163
ParticipantsOG0172
ParticipantsOG0181
ParticipantsOG0193
ParticipantsOG0203
ParticipantsOG0213
ParticipantsOG0223
ParticipantsOG0233
ParticipantsOG0242
ParticipantsOG0253
ParticipantsOG0261
ParticipantsOG0271
ParticipantsOG0281
ParticipantsOG0293
ParticipantsOG0303
ParticipantsOG0312
ParticipantsOG0322
ParticipantsOG03318
Title
Measurements
OG002123.9± NANA = SD values were not reported when n\<2.
OG003122.9± NANA = SD values were not reported when n\<2.
OG00494.8± NANA = SD values were not reported when n\<2.
OG005
Cycle 2: Day 1; Pre-dose
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
ParticipantsOG0041
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0093
ParticipantsOG0102
ParticipantsOG0112
ParticipantsOG0123
ParticipantsOG0133
ParticipantsOG0142
ParticipantsOG0153
ParticipantsOG0162
ParticipantsOG0173
ParticipantsOG0181
ParticipantsOG0193
ParticipantsOG0203
ParticipantsOG0213
ParticipantsOG0223
ParticipantsOG0232
ParticipantsOG0242
ParticipantsOG0251
ParticipantsOG0261
ParticipantsOG0272
ParticipantsOG0282
ParticipantsOG0293
ParticipantsOG0303
ParticipantsOG0312
ParticipantsOG0322
ParticipantsOG03318
Title
Measurements
OG000106.0± NANA = SD values were not reported when n\<2.
OG003114.9± NANA = SD values were not reported when n\<2.
OG00492.2± NANA = SD values were not reported when n\<2.
OG005
533
± NA
NA = %GCV values were not reported when n\<2.
OG0071490± NANA = %GCV values were not reported when n\<2.
OG008607± NANA = %GCV values were not reported when n\<2.
OG00911400± 42.0
OG01013700± 46.6
OG01114400± 92.7
OG01231900± 27.2
OG01377100± 140.5
OG01451500± 38.3
OG015115000± 59.1
OG016120000± 59.2
OG017168000± 20.0
OG018228000± 45.7
OG019364000± 33.5
OG020660± 46.3
OG0214010± 11.4
OG022541± 31149.1
OG02318500± 17.5
OG02417900± 52.5
OG02527900± 7.4
OG02632500± 36.2
OG02738100± 25.6
OG02865000± 20.7
OG029105000± 21.6
OG030118000± 14.7
OG031175000± 3.2
OG032271000± 8.1
OG033231000± 173.3
8940
± 100.6
OG01013400± 37.5
OG01116200± 68.9
OG01229100± 53.5
OG01342000± 16.3
OG01452700± 45.8
OG01588700± 11.8
OG016115000± 49.4
OG017147000± NANA = %GCV values were not reported when n\<2.
OG018247000± NANA = %GCV values were not reported when n\<2.
OG019389000± 24.4
OG020803± 26.2
OG0213600± 361.8
OG0222190± 263.1
OG02318800± 41.8
OG02417400± 72.1
OG02530300± 11.0
OG02637300± 23.4
OG02748800± 45.6
OG02896800± 62.8
OG029111000± 20.6
OG030117000± 35.7
OG031193000± 18.1
OG032321000± 19.3
OG033333000± 22.4
38800
± 39.1
OG01467300± 47.9
OG01588800± 18.3
OG01686800± 28.8
OG018256000± NANA = %GCV values were not reported when n\<2.
OG019501000± NANA = %GCV values were not reported when n\<2.
OG02042.9± NANA = %GCV values were not reported when n\<2.
OG02210400± NANA = %GCV values were not reported when n\<2.
OG02314200± 48.0
OG02416900± 110.1
OG02526600± 12.3
OG02740600± 43.7
OG02843200± NANA = %GCV values were not reported when n\<2.
OG029126000± 42.5
OG030207000± NANA = %GCV values were not reported when n\<2.
OG032318000± 2.0
OG033386000± 22.0
0.02
(0.02 to 0.02)
OG0070.02(0.02 to 0.02)
OG0080.03(0.03 to 0.03)
OG0090.03(0.02 to 0.08)
OG0100.03(0.03 to 0.08)
OG0110.05(0.02 to 0.08)
OG0120.03(0.02 to 0.08)
OG0130.02(0.02 to 0.03)
OG0140.07(0.02 to 0.08)
OG0150.47(0.02 to 0.91)
OG0160.02(0.02 to 0.09)
OG0170.03(0.02 to 0.08)
OG0180.02(0.02 to 0.08)
OG0190.02(0.02 to 0.08)
OG0200.03(0.02 to 0.08)
OG0210.03(0.03 to 0.03)
OG0220.02(0.02 to 0.1)
OG0230.02(0.02 to 0.9)
OG0240.08(0.02 to 0.08)
OG0250.05(0.02 to 0.08)
OG0260.03(0.02 to 0.03)
OG0270.02(0.02 to 0.08)
OG0280.03(0.02 to 0.90)
OG0290.08(0.03 to 0.08)
OG0300.02(0.02 to 0.08)
OG0310.08(0.08 to 0.08)
OG0320.06(0.03 to 0.08)
OG0330.08(0.02 to 1.08)
0.03
(0.02 to 0.08)
OG0100.02(0.02 to 0.08)
OG0110.05(0.02 to 0.08)
OG0120.03(0.02 to 0.09)
OG0130.02(0.02 to 0.08)
OG0140.02(0.02 to 0.07)
OG0150.08(0.08 to 0.08)
OG0160.08(0.02 to 0.08)
OG0170.08(0.08 to 0.08)
OG0180.02(0.02 to 0.02)
OG0190.02(0.02 to 0.08)
OG0200.03(0.03 to 0.03)
OG0210.03(0.03 to 0.03)
OG0220.06(0.04 to 0.09)
OG0230.02(0.02 to 0.11)
OG0240.08(0.02 to 0.08)
OG0250.03(0.02 to 0.03)
OG0260.08(0.03 to 0.08)
OG0270.03(0.02 to 0.08)
OG0280.08(0.02 to 0.08)
OG0290.02(0.02 to 0.08)
OG0300.02(0.02 to 0.09)
OG0310.05(0.02 to 0.08)
OG0320.02(0.02 to 0.02)
OG0330.03(0.02 to 0.09)
0.05
(0.02 to 0.08)
OG0140.02(0.02 to 0.02)
OG0150.03(0.02 to 0.03)
OG0160.06(0.02 to 0.09)
OG0180.02(0.02 to 0.02)
OG0190.02(0.02 to 0.02)
OG0200.03(0.03 to 0.03)
OG0220.09(0.09 to 0.09)
OG0230.08(0.08 to 0.08)
OG0240.05(0.02 to 0.08)
OG0250.02(0.02 to 0.03)
OG0270.08(0.03 to 0.08)
OG0280.02(0.02 to 0.02)
OG0290.05(0.02 to 0.09)
OG0300.02(0.02 to 0.02)
OG0320.08(0.08 to 0.08)
OG0330.08(0.02 to 0.09)
3.42
± NA
NA = %GCV values were not reported when n\<2.
OG0071.88± NANA = %GCV values were not reported when n\<2.
OG008NA± NANA = t½ was not calculable.
OG0094.53± 171.6
OG0107.21± 167.8
OG0111.31± 2100.9
OG0129.95± 38.4
OG0135.82± 65.6
OG0148.97± 39.5
OG01511.4± 123.7
OG01613.1± 32.8
OG01710.2± 13.0
OG01811.2± 49.6
OG01914.1± 36.7
OG0203.74± 486.6
OG0211.38± 158.1
OG0224.55± 318
OG02310.5± 62.9
OG0246.92± 82.0
OG0255.82± 33.3
OG02611.7± 14.3
OG0279.22± 106.0
OG02812.4± 36.6
OG02915.7± 10.9
OG0307.43± 111.8
OG03111.7± 12.3
OG03216.2± 5.36
OG03313.2± 56.4
3.11
± 120.5
OG0104.52± 376.5
OG01111.9± NANA = %GCV values were not reported when n\<2.
OG0126.54± 54.0
OG0139.59± 44.8
OG0143.61± 787.8
OG01511.9± 12.4
OG01611.9± 29.2
OG01711.3± NANA = %GCV values were not reported when n\<2.
OG01810.4± NANA = %GCV values were not reported when n\<2.
OG01921.4± 60
OG0202.19± 394.0
OG0213.72± 88.5
OG02216.6± NANA = %GCV values were not reported when n\<2.
OG02310.4± 95.0
OG0247.32± 92.3
OG0255.10± 23.4
OG0267.91± 23.9
OG0279.97± 30.5
OG02812.3± 46.1
OG02922.1± 50.8
OG0305.75± 269.1
OG03117.6± NANA = %GCV values were not reported when n\<2.
OG03215.7± 18.6
OG03321.6± 85.4
NA
± NA
NA = t½ was not calculable.
OG0147.43± 139.3
OG0158.14± 11.5
OG01617.8± NANA = %GCV values were not reported when n\<2.
OG0183.91± NANA = %GCV values were not reported when n\<2.
OG019NANA = %GCV values were not reported when n\<2.
OG020NANA = t½ was not calculable.
OG0227.12± NANA = %GCV values were not reported when n\<2.
OG0236.68± 103.1
OG02413.1± NANA = %GCV values were not reported when n\<2.
OG0256.27± 8.1
OG02713.8± 34.5
OG02814.8± NANA = %GCV values were not reported when n\<2.
OG02916.4± 27.6
OG03013.0± NANA = %GCV values were not reported when n\<2.
OG03212.0± NANA = %GCV values were not reported when n\<2.
OG03317.2± 48.6
2610
± NA
NA = %GCV values were not reported when n\<2.
OG0073510± NANA = %GCV values were not reported when n\<2.
OG008NA± NANA = %GCV values were not reported when n\<2.
OG00948600± 226.2
OG01051800± 660.7
OG01114500± 19927.0
OG012273000± 50.1
OG013223000± 45.6
OG014401000± 55.9
OG015860000± 53.4
OG0161160000± 72.1
OG0171590000± 33.3
OG0182090000± 19.8
OG0194580000± 21.1
OG0201120± 120.6
OG0217330± 150.8
OG0226380± 503154.6
OG023167000± 56.9
OG024116000± 121.4
OG025216000± 32.4
OG026278000± 37.1
OG027279000± 84.3
OG028594000± 27.1
OG0291170000± 15.1
OG030678000± 305.7
OG0311760000± 11.9
OG0323280000± 5.08
OG0332880000± 49.0
17400
± 711.2
OG01055700± 733.9
OG011235000± NANA = %GCV values were not reported when n\<2.
OG012217000± 87.0
OG013306000± 32.2
OG014173000± 658.5
OG015749000± 6.8
OG0161180000± 69.4
OG0171370000± NANA = %GCV values were not reported when n\<2.
OG0182390000± NANA = %GCV values were not reported when n\<2.
OG0195410000± 4.01
OG0201110± 104.1
OG02133900± 8.86
OG02279300± NANA = %GCV values were not reported when n\<2.
OG023182000± 81.4
OG024123000± 156.1
OG025152000± 11.5
OG026301000± 27.7
OG027330000± 79.3
OG028631000± 10.4
OG0291310000± 18.8
OG030692000± 277.7
OG0312220000± NANA = %GCV values were not reported when n\<2.
OG0323440000± 7.9
OG0333790000± 28.7
NA
± NA
NA = AUC0-21 was not calculable.
OG014503000± 133.9
OG015716000± 0.359
OG0161410000± NANA = %GCV values were not reported when n\<2.
OG0181400000± NANA = %GCV values were not reported when n\<2.
OG019NANA = AUC0-21 was not calculable.
OG020NANA = AUC0-21 was not calculable.
OG02280400± NANA = %GCV values were not reported when n\<2.
OG023107000± 136.8
OG024353000± NANA = %GCV values were not reported when n\<2.
OG025148000± 24.9
OG027394000± 66.0
OG028575000± NANA = %GCV values were not reported when n\<2.
OG0291580000± 46.2
OG0302350000± NANA = %GCV values were not reported when n\<2.
OG0323800000± NANA = %GCV values were not reported when n\<2.
OG0334360000± 33.7
2010
± NA
NA = %GCV values were not reported when n\<2.
OG0071780± NANA = %GCV values were not reported when n\<2.
OG00821.1± NANA = %GCV values were not reported when n\<2.
OG00948600± 226.2
OG01051600± 660.6
OG01114400± 20883.7
OG012268000± 49.1
OG013223000± 45.3
OG014128000± 759.0
OG015864000± 54.7
OG0161160000± 72.3
OG017635000± 247.7
OG0181790000± 31.7
OG0192620000± 116.6
OG0201110± 118.9
OG0216510± 182.3
OG022309± 4954684876.5
OG023167000± 56.9
OG024115000± 121.4
OG025228000± 40.9
OG026280000± 35.7
OG027280000± 83.6
OG028616000± 25.9
OG0291170000± 13.7
OG030681000± 307.0
OG0311710000± 15.7
OG0323770000± 25.4
OG0331710000± 371.9
19600
± 351.9
OG01051400± 640.7
OG01125300± 14504.2
OG012172000± 69.1
OG013281000± 19.5
OG014168000± 728.3
OG015756000± 5.0
OG0161110000± 59.1
OG0171110000± NANA = %GCV values were not reported when n\<2.
OG0182400000± NANA = %GCV values were not reported when n\<2.
OG0191910000± 294
OG020740± 53.9
OG0214070± 18558.6
OG0225130± 177486.3
OG023162000± 63.3
OG024118000± 153.4
OG025153000± 12.2
OG026219000± 18.5
OG027323000± 80.9
OG028579000± 14.8
OG029638000± 195.6
OG030443000± 353.2
OG031473000± 480.0
OG0323480000± 6.2
OG0333920000± 29.1
79100
± 265.0
OG014184000± 174.6
OG015379000± 5.5
OG016254000± 175.0
OG018433000± NANA = %GCV values were not reported when n\<2.
OG019469000± NANA = %GCV values were not reported when n\<2.
OG0201.72± NANA = %GCV values were not reported when n\<2.
OG02246000± NANA = %GCV values were not reported when n\<2.
OG02380800± 140.8
OG02412600± 1377431.1
OG025142000± 39.4
OG027365000± 44.1
OG028574000± NANA = %GCV values were not reported when n\<2.
OG0291580000± 46.6
OG0302280000± NANA = %GCV values were not reported when n\<2.
OG032975000± 99.2
OG0332750000± 135.4
2660
± NA
NA = %GCV values were not reported when n\<2.
OG0073490± NANA = %GCV values were not reported when n\<2.
OG008NA± NANA = AUC0-inf was not calculable.
OG00958600± 326.9
OG01068800± 1111.6
OG01115400± 28630.7
OG012360000± 68.6
OG013252000± 59.2
OG014503000± 78.7
OG0151280000± 6.1
OG0161740000± 71.9
OG0172090000± 39.2
OG0182950000± 4.1
OG0197270000± 0.2
OG0201550± 49.7
OG0217010± 176.2
OG0227660± 2164569.0
OG023232000± 92.0
OG024141000± 168.9
OG025238000± 40.4
OG026392000± 38.9
OG027385000± 150.0
OG028849000± 15.3
OG0291930000± 20.7
OG030874000± 450.1
OG0312500000± 18.6
OG0325570000± 8.3
OG0334520000± 70.6
18700
± 896.0
OG01070000± 1119.8
OG011330000± NANA = %GCV values were not reported when n\<2.
OG012251000± 105.1
OG013396000± 53.5
OG014216000± 1232.6
OG0151050000± 2.7
OG0161690000± 69.9
OG0171880000± NANA = %GCV values were not reported when n\<2.
OG0183190000± NANA = %GCV values were not reported when n\<2.
OG01911300000± 33.8
OG0201210± 104.1
OG02135700± 1.4
OG022136000± NANA = %GCV values were not reported when n\<2.
OG023261000± 123.7
OG024155000± 236.1
OG025162000± 15.6
OG026360000± 28.9
OG027430000± 86.6
OG028915000± 17.1
OG0292740000± 52.3
OG030909000± 438.2
OG0313910000± NANA = %GCV values were not reported when n\<2.
OG0325690000± 2.23
OG0338000000± 82.8
NA
± NA
NA = AUC0-inf was not calculable.
OG014644000± 228.9
OG015862000± 4.6
OG0162520000± NANA = %GCV values were not reported when n\<2.
OG0181460000± NANA = %GCV values were not reported when n\<2.
OG019NA± NANA = AUC0-inf was not calculable.
OG020NA± NANA = AUC0-inf was not calculable.
OG02292300± NANA = %GCV values were not reported when n\<2.
OG023129000± 200.9
OG024524000± NANA = %GCV values were not reported when n\<2.
OG025164000± 22.9
OG027609000± 96.4
OG028914000± NANA = %GCV values were not reported when n\<2.
OG0292720000± 67.4
OG0303480000± NANA = %GCV values were not reported when n\<2.
OG0325400000± NANA = %GCV values were not reported when n\<2.
OG0337910000± 54.9
0.142
± NA
NA = %GCV values were not reported when n\<2.
OG0070.940± NANA = %GCV values were not reported when n\<2.
OG008NA± NANA = CL was not calculable.
OG0090.617± 226.2
OG0100.811± 660.7
OG0114.06± 19927.0
OG0120.301± 50.1
OG0130.538± 45.6
OG0140.424± 55.9
OG0150.279± 53.4
OG0160.293± 72.1
OG0170.302± 33.3
OG0180.321± 19.8
OG0190.197± 21.1
OG0200.98± 120.6
OG0210.450± 150.8
OG0221.57± 503154.6
OG0230.182± 60.1
OG0240.362± 121.4
OG0250.273± 32.4
OG0260.294± 37.1
OG0270.430± 84.3
OG0280.286± 27.1
OG0290.205± 15.1
OG0300.502± 305.7
OG0310.272± 11.9
OG0320.204± 5.1
OG0330.313± 49.0
1.73
± 711.2
OG0100.754± 733.9
OG0110.251± NANA = %GCV values were not reported when n\<2.
OG0120.378± 87.0
OG0130.392± 32.2
OG0140.982± 658.5
OG0150.321± 6.8
OG0160.288± 69.4
OG0170.349± NANA = %GCV values were not reported when n\<2.
OG0180.280± NANA = %GCV values were not reported when n\<2.
OG0190.166± 4.0
OG0200.987± 104.1
OG0210.0973± 8.86
OG0220.126± NANA = %GCV values were not reported when n\<2.
OG0230.165± 81.4
OG0240.341± 156.1
OG0250.388± 11.5
OG0260.273± 27.7
OG0270.364± 79.3
OG0280.269± 10.4
OG0290.183± 18.8
OG0300.491± 277.7
OG0310.217± NANA = %GCV values were not reported when n\<2.
OG0320.195± 7.9
OG0330.238± 28.7
NA
± NA
NA = CL was not calculable.
OG0140.338± 133.9
OG0150.335± 0.4
OG0160.241± NANA = %GCV values were not reported when n\<2.
OG0180.477± NANA = %GCV values were not reported when n\<2.
OG019NA± NANA = CL was not calculable.
OG020NA± NANA = CL was not calculable.
OG0220.124± NANA = %GCV values were not reported when n\<2.
OG0230.282± 136.8
OG0240.119± NANA = %GCV values were not reported when n\<2.
OG0250.398± 24.9
OG0270.305± 66.0
OG0280.296± NANA = %GCV values were not reported when n\<2.
OG0290.152± 46.2
OG0300.145± NANA = %GCV values were not reported when n\<2.
OG0320.176± NANA = %GCV values were not reported when n\<2.
OG0330.206± 33.7
0.722
± NA
NA = %GCV values were not reported when n\<2.
OG0072.41± NANA = %GCV values were not reported when n\<2.
OG008NA± NANA = V was not calculable.
OG0093.75± 27.1
OG0106.59± 46.1
OG0113.91± NANA = %GCV values were not reported when n\<2.
OG0124.25± 11.0
OG0134.40± 14.9
OG0145.10± 2.5
OG0154.41± 263.0
OG0165.44± 88.1
OG0174.42± 21.1
OG0185.19± 75.3
OG0194.11± 63.3
OG0205.61± 3589.3
OG0210.870± 13.1
OG0222.97± 96.8
OG0232.76± 3.1
OG0243.67± 35.8
OG0252.41± 3.0
OG0264.9± 40.3
OG0275.89± 18.4
OG0284.77± 58.9
OG0294.58± 10.6
OG0304.36± 23.7
OG0314.68± 2.0
OG0324.83± 0.5
OG0335.94± 36.7
6.13
± 84.5
OG0104.76± 34.1
OG0114.15± NANA = %GCV values were not reported when n\<2.
OG0123.62± 28.9
OG0135.14± 17.2
OG0145.54± 8.6
OG0155.25± 11.9
OG0164.87± 83.3
OG0175.53± NANA = %GCV values were not reported when n\<2.
OG0184.24± NANA = %GCV values were not reported when n\<2.
OG0195.2± 61.6
OG0205.45± 862.6
OG0210.499± 111.2
OG0223.01± NANA = %GCV values were not reported when n\<2.
OG0232.5± 42.7
OG0243.56± 62.3
OG0252.90± 8.8
OG0263.10± 39.1
OG0274.96± 69.5
OG0284.62± 50.2
OG0295.7± 25.2
OG0303.97± 12.2
OG0315.41± NANA = %GCV values were not reported when n\<2.
OG0324.38± 25.2
OG0337.23± 61.1
NA
± NA
NA = V was not calculable.
OG0143.55± 5.0
OG0153.97± 12.0
OG0166.16± NANA = %GCV values were not reported when n\<2.
OG0182.82± NANA = %GCV values were not reported when n\<2.
OG019NA± NANA = V was not calculable.
OG020NA± NANA = V was not calculable.
OG0221.27± NANA = %GCV values were not reported when n\<2.
OG0232.71± 16.6
OG0242.22± NANA = %GCV values were not reported when n\<2.
OG0253.49± 32.9
OG0275.93± 23.7
OG0286.29± NANA = %GCV values were not reported when n\<2.
OG0293.61± 16.4
OG0302.72± NANA = %GCV values were not reported when n\<2.
OG0323.04± NANA = %GCV values were not reported when n\<2.
OG0335.14± 37.4
16200
± 109.6
OG02473000± 35.9
OG02596800± 14.2
OG02685700± 40.7
OG02748700± 79.3
OG02878500± 12.5
OG02982300± 25.5
OG03086000± 17.4
OG03196600± 4.9
OG03294100± 12.9
OG03380100± 25.4
97200
± 18.7
OG02473000± 56.8
OG025115000± 9.2
OG02693100± 33.8
OG02779100± 38.7
OG02883200± 22.8
OG02976000± 52.2
OG03093200± 13.7
OG031115000± 11.7
OG03294100± 7.1
OG03394600± 17.3
105000
± 17.2
OG02496500± 31.6
OG025125000± 7.9
OG02783500± 57.6
OG02990800± 47.7
OG030143000± NANA = %GCV values were not reported when n\<2.
OG03295600± 4.66
OG03397400± 23.9
0.03
(0.02 to 0.13)
OG0240.02(0.02 to 0.08)
OG0250.05(0.03 to 0.07)
OG0260.03(0.03 to 0.07)
OG0270.13(0.03 to 14.1)
OG0280.05(0.03 to 0.07)
OG0290.03(0.02 to 0.03)
OG0300.06(0.06 to 0.13)
OG0310.07(0.06 to 0.08)
OG0320.02(0.02 to 0.02)
OG0330.03(0.02 to 1.92)
0.07
(0.02 to 0.94)
OG0240.02(0.02 to 0.08)
OG0250.05(0.02 to 0.08)
OG0260.03(0.02 to 0.07)
OG0270.05(0.03 to 0.06)
OG0280.05(0.03 to 0.06)
OG0290.93(0.02 to 14.16)
OG0300.02(0.02 to 0.06)
OG0310.08(0.02 to 0.13)
OG0320.10(0.07 to 0.13)
OG0330.05(0.02 to 0.13)
0.04
(0.02 to 0.07)
OG0240.04(0.02 to 0.07)
OG0250.07(0.07 to 0.07)
OG0270.03(0.02 to 0.03)
OG0297.07(0.02 to 14.13)
OG0300.10(0.10 to 0.10)
OG0320.02(0.02 to 0.03)
OG0330.03(0.02 to 0.94)
18.5
± 13.4
OG02414.4± 42.1
OG02516.0± 4.4
OG02615.0± 9.17
OG02718.6± 38.1
OG02812.7± 22.4
OG02915.7± 9.65
OG03013.7± 18.6
OG03118.9± 1.03
OG03217.6± 35.9
OG03316.7± 55.1
15.2
± 49.2
OG02415.0± 122.9
OG02514.8± 5.7
OG0269.45± 35.3
OG02720.8± 15.4
OG0289.38± 6.03
OG02913.3± NANA = %GCV values were not reported when n\<2.
OG03011.3± 45.2
OG0318.11± 63.8
OG03219.8± 11.1
OG03324.9± 57.4
18.0
± 117.5
OG02434.1± NANA = %GCV values were not reported when n\<2.
OG02514.9± NANA = %GCV values were not reported when n\<2.
OG02723.3± 38.1
OG02922.4± NANA = %GCV values were not reported when n\<2.
OG03015.7± NANA = %GCV values were not reported when n\<2.
OG0326.94± 34.8
OG03316.6± 109.6
952000
± 12.6
OG024579000± 46.1
OG025871000± 16.5
OG026750000± 47.9
OG027739000± 48.8
OG028715000± 27.9
OG029921000± 18.1
OG030825000± 21.0
OG031991000± 14.5
OG032925000± 7.5
OG033825000± 32.1
1120000
± 14.1
OG024633000± 59.6
OG025927000± 8.1
OG026738000± 37.4
OG027903000± 50.6
OG028752000± 27.4
OG0291220000± NANA = %GCV values were not reported when n\<2.
OG030822000± 30.2
OG031883000± 25.5
OG032967000± 6.3
OG0331010000± 25.2
1050000
± 38.7
OG0241370000± NANA = %GCV values were not reported when n\<2.
OG0251010000± 14.7
OG027964000± 41.8
OG0291370000± NANA = %GCV values were not reported when n\<2.
OG0301460000± NANA = %GCV values were not reported when n\<2.
OG032810000± 27.7
OG033892000± 59.3
949000
± 12.7
OG024573000± 47.1
OG025985000± 34.7
OG026759000± 47.9
OG027567000± 62.3
OG028766000± 18.0
OG029932000± 15.8
OG030873000± 14.4
OG031958000± 9.49
OG0321080000± 29.5
OG033635000± 78.4
998000
± 4.5
OG024603000± 64.7
OG025938000± 6.3
OG026454000± 20.5
OG027747000± 32.3
OG028604000± 26.5
OG029455000± 192.8
OG030492000± 88.7
OG031264000± 343.2
OG032981000± 8.1
OG0331080000± 33.4
775000
± 110.7
OG02498800± 96422.3
OG0251120000± 72.3
OG0271020000± 33.7
OG0291280000± 8.0
OG0301410000± NANA = %GCV values were not reported when n\<2.
OG032284000± 95.5
OG033664000± 132.9
1700000
± 21.3
OG024915000± 75.1
OG0251410000± 19.6
OG0261210000± 50.6
OG0271390000± 24.5
OG0281030000± 19.3
OG0291540000± 16.3
OG0301260000± 23.3
OG0311820000± 13.2
OG0321620000± 27.2
OG0331470000± 57.8
1870000
± 36.7
OG0241110000± 149.0
OG0251450000± 7.0
OG026949000± 37.0
OG0271770000± 41.9
OG028954000± 30.3
OG0291870000± NANA = %GCV values were not reported when n\<2.
OG0301160000± 56.1
OG0311090000± 48.3
OG0321820000± 0.2
OG0332340000± 55.1
1980000
± 118.7
OG0243890000± NANA = %GCV values were not reported when n\<2.
OG0251430000± NANA = %GCV values were not reported when n\<2.
OG0272070000± 71.7
OG0292710000± NANA = %GCV values were not reported when n\<2.
OG0302440000± NANA = %GCV values were not reported when n\<2.
OG032931000± 38.4
OG0331730000± 112.9
0.210
± 12.6
OG0240.346± 46.1
OG0250.230± 16.5
OG0260.267± 47.9
OG0270.271± 48.9
OG0280.280± 27.9
OG0290.217± 18.1
OG0300.242± 20.9
OG0310.202± 14.5
OG0320.216± 7.5
OG0330.242± 32.1
0.178
± 14.1
OG0240.316± 59.5
OG0250.216± 8.1
OG0260.271± 37.4
OG0270.222± 50.7
OG0280.266± 27.4
OG0290.164± NANA = %GCV values were not reported when n\<2.
OG0300.243± 30.1
OG0310.227± 25.5
OG0320.207± 6.3
OG0330.199± 25.2
0.190
± 38.6
OG0240.146± NANA = %GCV values were not reported when n\<2.
OG0250.198± 14.7
OG0270.207± 41.9
OG0290.147± NANA = %GCV values were not reported when n\<2.
OG0300.137± NANA = %GCV values were not reported when n\<2.
OG0320.247± 27.7
OG0330.224± 59.3
5.29
± 9.3
OG0246.82± 32.9
OG0254.92± 11.1
OG0265.70± 44.1
OG0277.34± 92.9
OG0284.88± 41.7
OG0294.96± 20.0
OG0304.71± 23.3
OG0315.36± 16.6
OG0325.24± 22.5
OG0335.79± 38.6
3.94
± 39.5
OG0246.73± 53.6
OG0254.40± 7.7
OG0263.62± 55.0
OG0276.51± 62.6
OG0283.63± 20.5
OG0293.24± NANA = %GCV values were not reported when n\<2.
OG0304.01± 15.4
OG0312.64± 33.9
OG0325.66± 14.9
OG0337.09± 73.6
4.78
± 54.9
OG0247.05± NANA = %GCV values were not reported when n\<2.
OG0254.47± NANA = %GCV values were not reported when n\<2.
OG0276.85± 6.4
OG0294.31± NANA = %GCV values were not reported when n\<2.
OG0303.17± NANA = %GCV values were not reported when n\<2.
OG0322.46± 7.2
OG0335.48± 44.7
42.7
± NA
NA = SD values were not reported when n\<2.
OG00517.0± NANA = SD values were not reported when n\<2.
OG0062.4± NANA = SD values were not reported when n\<2.
OG0081.2± NANA = SD values were not reported when n\<2.
OG0090.7± NANA = SD values were not reported when n\<2.
OG0116.9± NANA = SD values were not reported when n\<2.
OG0204.9± 2.5
OG0213.0± 2.1
OG0228.1± 4.8
OG0239.1± NANA = SD values were not reported when n\<2.
55.4
± NA
NA = SD values were not reported when n\<2.
OG0059.5± NANA = SD values were not reported when n\<2.
OG0062.2± NANA = SD values were not reported when n\<2.
OG0083.3± NANA = SD values were not reported when n\<2.
OG00946.2± 86.4
OG01015.2± 3.0
OG0114.8± 1.0
OG01217.4± 24.6
OG01330.4± 34.6
OG0145.8± 5.2
OG01514.7± 7.1
OG01612.0± 8.9
OG0176.7± 2.6
OG01882.5± NANA = SD values were not reported when n\<2.
OG01920.0± 10.7
OG0206.1± 3.1
OG0212.4± 0.3
OG0227.3± 4.0
OG0237.1± 1.2
OG0246.5± 0.2
OG0257.4± 2.2
OG0266.7± 4.6
OG0285.9± 0.9
OG02911.4± 4.2
OG03023.0± 3.4
OG03126.0± 32.2
OG03213.7± NANA = SD values were not reported when n\<2.
OG03315.6± 20.8
72.4
± NA
NA = SD values were not reported when n\<2.
OG0055.4± NANA = SD values were not reported when n\<2.
OG0062.6± NANA = SD values were not reported when n\<2.
OG0080.9± NANA = SD values were not reported when n\<2.
OG00950.0± 70.1
OG0114.3± NANA = SD values were not reported when n\<2.
OG0207.2± 3.5
OG0212.4± 1.3
OG0223.9± 1.3
OG0231.6± NANA = SD values were not reported when n\<2.
OG0319.9± NANA = SD values were not reported when n\<2.
83.0
± NA
NA = SD values were not reported when n\<2.
OG0058.8± NANA = SD values were not reported when n\<2.
OG0061.7± NANA = SD values were not reported when n\<2.
OG0084.5± NANA = SD values were not reported when n\<2.
89.2
± NA
NA = SD values were not reported when n\<2.
OG00515.0± NANA = SD values were not reported when n\<2.
OG0068.2± NANA = SD values were not reported when n\<2.
OG009148.6± 281.6
OG0105.8± 4.3
OG0116.3± 5.1
OG01210.0± 8.3
OG01310.2± 3.6
OG0142.2± 0.4
OG01516.0± 9.4
OG01619.3± 15.3
OG01722.5± 12.6
OG01882.9± NANA = SD values were not reported when n\<2.
OG01915.5± 11.3
OG02010.2± 8.9
OG0212.9± 2.3
OG0225.4± 4.6
OG02312.8± 7.1
OG0243.8± 1.8
OG0256.0± 4.9
OG0269.3± 4.9
OG0278.6± NANA = SD values were not reported when n\<2.
OG0284.0± NANA = SD values were not reported when n\<2.
OG02911.8± 7.0
OG03012.0± 5.6
OG03125.3± 3.0
OG0328.8± NANA = SD values were not reported when n\<2.
OG03311.3± 13.1
74.8
± NA
NA = SD values were not reported when n\<2.
OG00671.4± NANA = SD values were not reported when n\<2.
OG00871.2± NANA = SD values were not reported when n\<2.
OG009169.3± 301.5
OG0102.2± 1.6
OG0114.0± NANA = SD values were not reported when n\<2.
OG01240.9± 28.1
OG0136.5± NANA = SD values were not reported when n\<2.
OG0148.9± 13.8
OG01515.2± 15.9
OG0168.1± 6.7
OG0174.8± 2.7
OG01865.8± NANA = SD values were not reported when n\<2.
OG01915.5± 5.6
OG02039.9± 49.1
OG0214.8± 1.8
OG0228.8± 9.2
OG02311.4± 8.7
OG0245.0± 4.3
OG0259.1± 4.8
OG02628.6± NANA = SD values were not reported when n\<2.
OG02712.5± NANA = SD values were not reported when n\<2.
OG02822.2± NANA = SD values were not reported when n\<2.
OG0293.8± 1.5
OG03040.8± 54.4
OG03122.5± 8.7
OG03221.9± 17.6
OG03313.0± 14.0
80.3
± NA
NA = SD values were not reported when n\<2.
OG00884.8± NANA = SD values were not reported when n\<2.
OG00949.3± 84.6
OG01057.1± 52.9
OG01167.4± 91.5
OG0127.6± 5.5
OG0137.8± 3.8
OG01429.3± 28.1
OG01544.8± 62.4
OG01617.7± 5.7
OG01739.0± 50.0
OG01877.0± NANA = SD values were not reported when n\<2.
OG0197.0± 3.6
OG020109.9± 37.2
OG02174.1± 36.4
OG02270.0± 51.8
OG02311.7± 7.9
OG02412.6± 6.9
OG02513.5± NANA = SD values were not reported when n\<2.
OG02651.2± NANA = SD values were not reported when n\<2.