A Dose-Escalation Study for Patients With Advanced Cancer | NCT01214642 | Trialant
NCT01214642
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Aug 6, 2018Actual
Enrollment
63Actual
Phase
Phase 1
Conditions
Advanced Cancer
Interventions
pegfilgrastim
LY2523355
Countries
United States
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
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT01214642
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
11619
Secondary IDs
ID
Type
Description
Link
I1Y-MC-JFBB
Other Identifier
Eli Lilly and Company
Brief Title
A Dose-Escalation Study for Patients With Advanced Cancer
Official Title
A Phase 1 Dose-Escalation Study of LY2523355 in Patients With Advanced Cancer
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Aug 2018
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
May 2008
Primary Completion Date
Dec 2011Actual
Completion Date
Jun 2012Actual
First Submitted Date
Oct 1, 2010
First Submission Date that Met QC Criteria
Oct 4, 2010
First Posted Date
Oct 5, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 27, 2017
Results First Submitted that Met QC Criteria
Aug 3, 2018
Results First Posted Date
Aug 6, 2018Actual
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
Aug 3, 2018
Last Update Posted Date
Aug 6, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
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 study is being conducted to determine the safety of LY2523355 for the treatment of advanced and/or metastatic cancer (including Non-Hodgkin's lymphoma).
Detailed Description
This study is a multi-center, non-randomized, open label, dose-escalation, Phase 1 study of intravenous LY2523355 in patients with advanced and/or metastatic cancer (including non-Hodgkin's lymphoma) for whom no treatment of higher priority exists.
Conditions Module
Conditions
Advanced Cancer
Keywords
Advanced Cancer
Cancer
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
63Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
LY2523355 Days 1, 5, 9
Experimental
LY2523355 administered intravenously on Days 1, 5 and 9, starting dose is 2 milligrams per meter squared (mg/m^2) for 2 planned 21-day cycles. Participants may continue on study drug until disease progression, unacceptable toxicity or other withdrawal criterion are met.
Drug: LY2523355
LY2523355 Days 1, 8
Experimental
LY2523355 administered intravenously on Days 1 and 8, starting dose is 8 mg/m^2 for 2 planned 21-day cycles. Participants may continue on study drug until disease progression, unacceptable toxicity or other withdrawal criterion are met.
Drug: LY2523355
LY2523355 Days 1, 5 + pegfilgrastim
Experimental
LY2523355 administered intravenously on Days 1 and 5, starting dose is 8 mg/m^2 for 2 planned 21-day cycles and 6 mg pegfilgrastim administered subcutaneously on Day 6 of each 21-day cycle for the 2 planned cycles and for any subsequent cycles of LY2523355 received. Participants may continue on study drug until disease progression, unacceptable toxicity or other withdrawal criterion are met.
Drug: pegfilgrastim
Drug: LY2523355
LY2523355 Days 1, 4 + pegfilgrastim
Experimental
LY2523355 administered on Days 1 and 4, starting dose is 12 mg/m^2 for 2 planned 21-day cycles and 6 mg pegfilgrastim administered subcutaneously on Day 5 of each 21-day cycle for the 2 planned cycles and for any subsequent cycles of LY2523355 received. Participants may continue on study drug until disease progression, unacceptable toxicity or other withdrawal criterion are met.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
pegfilgrastim
Drug
Administered subcutaneously
LY2523355 Days 1, 4 + pegfilgrastim
LY2523355 Days 1, 5 + pegfilgrastim
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Recommended Dose and Schedule for Phase 2 Studies
The recommended dose and schedule for Phase 2 studies is defined as the maximum tolerated dose (MTD). MTD is defined as the dose level at which no more than 2 dose limiting toxicities (DLTs), no more than 3 dose reductions (DR) or dose omissions (DO) and no more than 1 DLT plus 2 DR/DO occurred. DLT is defined as an adverse event (AE) occurring in Cycle 1 with the following criteria according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0: Any ≥Grade 3 nonhematological toxicity (except nausea/vomiting or diarrhea controlled with treatment or fatigue); ≥Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia with bleeding; Grade 4 hematological toxicity of >5 days duration, excluding thrombocytopenia; febrile neutropenia.
Cycle 1 (21 days): Day 1, 5 and 9, any AE reported
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Clinically Significant Effects
Clinically significant effects were defined as serious and other non-serious adverse events (AEs). A summary of serious and other non-serious AEs is located in the Reported Adverse Events module.
Baseline to Cycle 38 (21-day cycles): daily for AEs
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Have a diagnosis of advanced and/or metastatic cancer (solid tumors or Non-Hodgkin's lymphoma) that is refractory to standard therapy or for which no proven effective therapy exists. Participants entering the dose confirmation phase (Part B) of the study must also have a tumor that is safely amenable to serial biopsies
Have the presence of measurable or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) or Revised International Working Group Lymphoma Response Criteria
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy, or other investigational therapy for at least 28 days (6 weeks for mitomycin-C or nitrosoureas) prior to study enrollment
Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug
Females with child bearing potential must have had a negative urine or serum pregnancy test less than or equal to 7 days prior to the first dose of study drug
Have an estimated life expectancy of greater than or equal to 12 weeks.
Exclusion Criteria:
Have symptomatic, untreated or uncontrolled central nervous system (CNS) metastases. Participants with treated CNS metastases are eligible provided their disease is radiographically stable, asymptomatic, and they are not currently receiving corticosteroids and/or anticonvulsants. Screening of asymptomatic participants without history of CNS metastases is not required
Have current acute or chronic leukemia
Have had an autologous or allogenic bone marrow transplant
Females who are pregnant or lactating
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Nashville
Tennessee
37203
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Part A is the LY2523355 dose escalation phase and Part B is the LY2523355 dose confirmation phase. The reasons for discontinuation listed in the participant flow are the reasons the participant discontinued treatment and a participant was considered to have "completed" the trial if they received at 2 cycles of treatment.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A - Days 1, 5, 9 - 2 mg/m^2/Day
2 milligrams per meter squared per day (mg/m^2/day) LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
FG001
Part A - Days 1, 5, 9 - 4 mg/m^2/Day
4 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
FG002
Part A - Days 1, 5, 9 - 8 mg/m^2/Day
8 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
FG003
Part A - Days 1, 5, 9 - 7 mg/m^2/Day
7 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
FG004
Part A - Days 1, 5, 9 - 6 mg/m^2/Day
6 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
FG005
Part A - Days 1, 5, 9 - 5 mg/m^2/Day
5 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
FG006
Part A - Days 1, 8 - 8 mg/m^2/Day
8 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 8 of 21-day cycle.
FG007
Part A - Days 1, 5+PEG - 8 mg/m^2/Day
8 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus pegfilgrastim (PEG) administered subcutaneously on Day 6.
FG008
Part A and B- Days 1, 5+PEG - 12 mg/m^2/Day
12 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
FG009
Part A - Days 1, 5+PEG - 16 mg/m^2/Day
16 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
FG010
Part A - Days 1, 5+PEG - 14 mg/m^2/Day
14 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
FG011
Part B - Days 1, 4+PEG - 12 mg/m^2/Day
12 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 4 of 21-day cycle plus PEG administered subcutaneously on Day 5.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0003 subjects
FG0013 subjects
FG0026 subjects
FG0036 subjects
FG0046 subjects
FG0053 subjects
FG0066 subjects
FG0073 subjects
FG00813 subjectsAll participants who received 12 mg/m2/day on Days 1 and 5 plus PEG in Part A and Part B.
FG0094 subjects
FG0104 subjects
FG0116 subjects
Received at Least 1 Dose of Study Drug
FG0003 subjects
FG0013 subjects
FG0026 subjects
FG0036 subjects
Complete at Least 2 Cycles of Study Drug
FG0003 subjects
FG0011 subjects
FG0025 subjects
FG0034 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0003 subjects
FG0013 subjects
FG0026 subjects
FG0036 subjects
FG004
Type
Comment
Reasons
Progressive Disease
FG0003 subjects
FG0012 subjects
FG0023 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
All participants who received at least 1 dose of LY2523355.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A - Days 1, 5, 9 - 2 mg/m^2/Day
2 milligrams per meter squared per day (mg/m^2/day) LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
BG001
Part A - Days 1, 5, 9 - 4 mg/m^2/Day
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
Recommended Dose and Schedule for Phase 2 Studies
The recommended dose and schedule for Phase 2 studies is defined as the maximum tolerated dose (MTD). MTD is defined as the dose level at which no more than 2 dose limiting toxicities (DLTs), no more than 3 dose reductions (DR) or dose omissions (DO) and no more than 1 DLT plus 2 DR/DO occurred. DLT is defined as an adverse event (AE) occurring in Cycle 1 with the following criteria according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0: Any ≥Grade 3 nonhematological toxicity (except nausea/vomiting or diarrhea controlled with treatment or fatigue); ≥Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia with bleeding; Grade 4 hematological toxicity of >5 days duration, excluding thrombocytopenia; febrile neutropenia.
All participants who received at least 1 dose of LY2523355.
Posted
Number
mg/m^2/day
Cycle 1 (21 days): Day 1, 5 and 9, any AE reported
ID
Title
Description
OG000
LY2523355 / LY2523355 +PEG
Adverse Events Module
Frequency Threshold
5
Time Frame
Not provided
Description
Not provided
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
Part A - Days 1, 5, 9 - 2 mg/m^2/Day
Part A (Dose Escalation Phase): 2 milligrams per meter squared per day (mg/m^2/day) LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 12.0
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 12.0
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
Chief Medical Officer
Eli Lilly and Company
800-545-5979
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D009369
Neoplasms
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
C455861
pegfilgrastim
C000591843
litronesib
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: pegfilgrastim
Drug: LY2523355
LY2523355
Drug
Administered intravenously
LY2523355 Days 1, 4 + pegfilgrastim
LY2523355 Days 1, 5 + pegfilgrastim
LY2523355 Days 1, 5, 9
LY2523355 Days 1, 8
Pharmacokinetics Maximum Concentration (Cmax), Single Dose
Plasma Cmax following a single dose of LY2523355 at each dose level across all schedules and in the presence or absence of pegfilgrastim (PEG).
Cycle 1 Day 1 of 21-day cycle: Predose, 1 hour (hr), 2,4,6,8,24,48 and 72 hr postdose
Pharmacokinetics Maximum Concentration (Cmax), Multiple Dose
Plasma Cmax following multiple doses of LY2523355 at each dose level across all schedules and in the presence or absence of pegfilgrastim (PEG).
Cycle 1 Days 4, 5, 8 or 9 of 21-day cycle:Predose, 1 hour (hr), 2,4,6,8,24,48 and 72 hr postdose
Pharmacokinetics Area Under the Concentration-time Curve (AUC), Single Dose
Plasma AUC from time zero to infinity [AUC(0-∞)] and AUC from time zero to 24 hours post-dose [AUC(0-24)] following a single dose of LY2523355 at each dose level across all schedules and in the presence or absence of pegfilgrastim (PEG).
Cycle 1 Days 4, 5, 8 or 9 of 21-day cycle:Predose, 1 hour (hr), 2,4,6,8,24,48 and 72 hr postdose
Pharmacokinetic Areas Under the Concentration Time Curve (AUC), Multiple Dose
Plasma AUC from time zero to infinity (0-∞) and AUC from time zero to 24 hours (0-24) post-dose following multiple doses of LY2523355 at each dose level across all schedules and in the presence or absence of pegfilgrastim (PEG).
Cycle 1 Days 4, 5, 8 or 9 of 21-day cycle:Predose, 1 hour (hr), 2,4,6,8,24,48 and 72 hr postdose
Number of Participants With Tumor Response
Response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST) criteria and the Revised International Working Group (IWG) lymphoma response criteria for lymphoma patients. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir. Tumor response is CR + PR.
Baseline to measured disease progression or discontinuation up to Cycle 38 (21-day cycles)
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
San Antonio
Texas
78229-3307
United States
FG004
6 subjects
FG0053 subjects
FG0066 subjects
FG0073 subjects
FG00813 subjects
FG0094 subjects
FG0104 subjects
FG0116 subjects
FG004
6 subjects
FG0051 subjects
FG0066 subjects
FG0073 subjects
FG00812 subjects
FG0092 subjects
FG0102 subjects
FG0115 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
6 subjects
FG0053 subjects
FG0066 subjects
FG0073 subjects
FG00813 subjects
FG0094 subjects
FG0104 subjects
FG0116 subjects
5 subjects
FG0045 subjects
FG0053 subjects
FG0065 subjects
FG0073 subjects
FG00810 subjects
FG0092 subjects
FG0101 subjects
FG0114 subjects
Adverse Event
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0101 subjects
FG0110 subjects
Death
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0110 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0083 subjects
FG0091 subjects
FG0101 subjects
FG0110 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0112 subjects
4 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
BG002
Part A - Days 1, 5, 9 - 8 mg/m^2/Day
8 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
BG003
Part A - Days 1, 5, 9 - 7 mg/m^2/Day
7 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
BG004
Part A - Days 1, 5, 9 - 6 mg/m^2/Day
6 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
BG005
Part A - Days 1, 5, 9 - 5 mg/m^2/Day
5 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
BG006
Part A - Days 1, 8 - 8 mg/m^2/Day
8 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 8 of 21-day cycle.
BG007
Part A - Days 1, 5+PEG - 8 mg/m^2/Day
8 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus pegfilgrastim (PEG) administered subcutaneously on Day 6.
BG008
Part A and B - Days 1, 5+PEG - 12 mg/m^2/Day
12 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6 in Part A and Part B.
BG009
Part A - Days 1, 5+PEG - 16 mg/m^2/Day
16 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
BG010
Part A - Days 1, 5+PEG - 14 mg/m^2/Day
14 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
BG011
Part B - Days 1, 4+PEG - 12 mg/m^2/Day
12 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 4 of 21-day cycle plus PEG administered subcutaneously on Day 5.
BG012
Total
Total of all reporting groups
3
BG0013
BG0026
BG0036
BG0046
BG0053
BG0066
BG0073
BG00813
BG0094
BG0104
BG0116
BG01263
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00066.60± 5.484
BG00148.07± 19.657
BG00259.73± 7.541
BG00361.67± 9.352
BG00458.45± 12.425
BG00556.73± 7.267
BG00659.77± 6.959
BG00767.10± 1.212
BG00862.02± 7.598
BG00957.10± 25.069
BG01060.18± 10.205
BG01159.43± 18.595
BG01260.08± 11.471
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0011
BG0024
BG0031
BG0044
BG0053
BG0062
BG0072
BG0084
BG0092
BG0103
BG0112
BG01230
Male
BG0001
BG0012
BG0022
BG0035
BG004
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Caucasian
BG0001
BG0011
BG0024
BG0036
BG0044
BG0053
BG0066
BG0073
BG00810
BG0094
BG0103
BG0116
BG01251
African
BG0001
BG0010
BG0021
BG0030
BG004
Hispanic
BG0001
BG0012
BG0021
BG0030
BG004
East Asian
BG0000
BG0010
BG0020
BG0030
BG004
West Asian (Indian sub-continent)
BG0000
BG0010
BG0020
BG0030
BG004
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG0003
BG0013
BG0026
BG0036
BG0046
BG0053
BG0066
BG0073
BG00813
BG0094
BG0104
BG0116
BG01263
Escalating doses starting at 2 milligrams per meter squared per day (mg/m^2/day) LY2523355 administered by intravenous infusion over 1 hour on Days 1, 5, and 9; escalating doses starting at 8 mg/m^2/day LY2523355 administered by intravenous infusion over 1 hour on Days 1 and 8 or Days 1 and 5 plus 6 mg pegfilgrastim (PEG) administered subcutaneously on Day 6; or 12 mg/m^2/day LY2523355 administered by intravenous infusion over 1 hour on Days 1 and 4 plus 6 mg PEG administered subcutaneously on Day 5 of 21-day cycle for 2 planned cycles and any subsequent cycle up to 38 cycles of 21-days. The maximum allowed dose was 30 mg/m^2/day.
Units
Counts
Participants
OG00063
Title
Denominators
Categories
Title
Measurements
OG0008
Secondary
Number of Participants With Clinically Significant Effects
Clinically significant effects were defined as serious and other non-serious adverse events (AEs). A summary of serious and other non-serious AEs is located in the Reported Adverse Events module.
All participants who had at least 1 dose of LY2523355.
Posted
Count of Participants
Participants
No
Baseline to Cycle 38 (21-day cycles): daily for AEs
ID
Title
Description
OG000
Part A - Days 1, 5, 9 - 2 mg/m^2/Day
2 milligrams per meter squared per day (mg/m^2/day) LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
OG001
Part A - Days 1, 5, 9 - 4 mg/m^2/Day
4 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
OG002
Part A - Days 1, 5, 9 - 8 mg/m^2/Day
8 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
OG003
Part A - Days 1, 5, 9 - 7 mg/m^2/Day
7 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
OG004
Part A - Days 1, 5, 9 - 6 mg/m^2/Day
6 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
OG005
Part A - Days 1, 5, 9 - 5 mg/m^2/Day
5 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
OG006
Part A - Days 1, 8 - 8 mg/m^2/Day
8 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 8 of 21-day cycle.
OG007
Part A - Days 1, 5+PEG - 8 mg/m2/Day
8 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus pegfilgrastim (PEG) administered subcutaneously on Day 6.
OG008
Part A - Days 1, 5+PEG - 12 mg/m^2/Day
12 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
OG009
Part A - Days 1, 5+PEG - 16 mg/m^2/Day
16 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
OG010
Part A - Days 1, 5+PEG - 14 mg/m^2/Day
14 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
OG011
Part B - Days 1, 5+PEG - 12 mg/m^2/Day
12 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
OG012
Part B - Days 1, 4+PEG - 12 mg/m^2/d
12 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 4 of 21-day cycle plus PEG administered subcutaneously on Day 5.
Units
Counts
Participants
OG0003
OG0013
OG0026
OG003
Title
Denominators
Categories
Serious AEs
Title
Measurements
OG0001
OG0012
OG0022
OG003
Secondary
Pharmacokinetics Maximum Concentration (Cmax), Single Dose
Plasma Cmax following a single dose of LY2523355 at each dose level across all schedules and in the presence or absence of pegfilgrastim (PEG).
All participants who received 1 dose of LY2523355 and had Cmax samples collected on Day 1 of Cycle 1.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms/milliliter (ng/mL)
Cycle 1 Day 1 of 21-day cycle: Predose, 1 hour (hr), 2,4,6,8,24,48 and 72 hr postdose
ID
Title
Description
OG000
2 mg/m^2/Day LY2523355
2 milligrams per meter squared per day (mg/m^2/day) LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
OG001
4 mg/m^2/Day LY2523355
4 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
OG002
5 mg/m^2/Day LY2523355
5 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
OG003
6 mg/m^2/Day LY2523355
6 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
OG004
7 mg/m^2/Day LY2523355
7 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
OG005
8 mg/m^2/Day LY2523355
8 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion across all schedules and in the presence or absence of PEG administered subcutaneously.
OG006
12 mg/m^2/Day LY2523355
12 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6 and on Days 1 and 4 of 21-day cycle plus PEG administered subcutaneously on Day 5.
OG007
14 mg/m^2/Day LY2523355
14 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
OG008
16 mg/m^2/Day LY2523355
16 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG00045.2± 25
OG001126± 31
OG002137± 81
OG003
Secondary
Pharmacokinetics Maximum Concentration (Cmax), Multiple Dose
Plasma Cmax following multiple doses of LY2523355 at each dose level across all schedules and in the presence or absence of pegfilgrastim (PEG).
All participants who received 2 doses of study drug and had a Cmax sample collected on Days 4, 5, 8 or 9 of Cycle 1 (based on schedule of administration) after multiple dose administration of LY2523355.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms/milliliter (ng/mL)
Cycle 1 Days 4, 5, 8 or 9 of 21-day cycle:Predose, 1 hour (hr), 2,4,6,8,24,48 and 72 hr postdose
ID
Title
Description
OG000
2 mg/m^2/Day LY2523355
2 milligrams per meter squared per day (mg/m^2/day) LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
OG001
4 mg/m^2/Day LY2523355
4 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
OG002
5 mg/m^2/Day LY2523355
5 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
OG003
6 mg/m^2/Day LY2523355
6 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
OG004
7 mg/m^2/Day LY2523355
7 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
OG005
8 mg/m^2/Day LY2523355
8 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion across all schedules and in the presence or absence of PEG administered subcutaneously.
OG006
12 mg/m^2/Day LY2523355
12 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6 and on Days 1 and 4 of 21-day cycle plus PEG administered subcutaneously on Day 5.
OG007
14 mg/m^2/Day LY2523355
14 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
OG008
16 mg/m^2/Day LY2523355
16 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG00049.1± 15
OG001121± 58
OG002196± 43
OG003
Secondary
Pharmacokinetics Area Under the Concentration-time Curve (AUC), Single Dose
Plasma AUC from time zero to infinity [AUC(0-∞)] and AUC from time zero to 24 hours post-dose [AUC(0-24)] following a single dose of LY2523355 at each dose level across all schedules and in the presence or absence of pegfilgrastim (PEG).
All participants who received 1 dose of LY2523355 and had pharmacokinetic samples collected on Day 1 of Cycle 1 to enable calculation of AUC(0-∞) and AUC(0-24).
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms*hour/milliter (ng*hr/mL)
Cycle 1 Days 4, 5, 8 or 9 of 21-day cycle:Predose, 1 hour (hr), 2,4,6,8,24,48 and 72 hr postdose
ID
Title
Description
OG000
2 mg/m^2/Day LY2523355
2 milligrams per meter squared per day (mg/m^2/day) LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
OG001
4 mg/m^2/Day LY2523355
4 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
OG002
5 mg/m^2/Day LY25233552
5 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
OG003
6 mg/m^2/Day LY2523355
6 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
OG004
7 mg/m^2/Day LY2523355
7 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
OG005
8 mg/m^2/Day LY2523355
8 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion across all schedules and in the presence or absence of PEG administered subcutaneously.
OG006
12 mg/m^2/Day LY2523355
12 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6 and on Days 1 and 4 of 21-day cycle plus PEG administered subcutaneously on Day 5.
OG007
14 mg/m^2/Day LY2523355
14 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
OG008
16 mg/m^2/Day LY2523355
16 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
AUC(0-∞)
Title
Measurements
OG000158± 55
OG001517± 71
OG002584± 70
OG003
Secondary
Pharmacokinetic Areas Under the Concentration Time Curve (AUC), Multiple Dose
Plasma AUC from time zero to infinity (0-∞) and AUC from time zero to 24 hours (0-24) post-dose following multiple doses of LY2523355 at each dose level across all schedules and in the presence or absence of pegfilgrastim (PEG).
All participants who received 2 doses of study drug and had pharmacokinetic samples collected on Day 4, 5, 8, or 9 of Cycle 1 (based on schedule of administration) to enable calculation of AUC(0-∞) and AUC(0-24) after multiple dose administration of LY2523355.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms*hour/milliliter (ng*hr/mL)
Cycle 1 Days 4, 5, 8 or 9 of 21-day cycle:Predose, 1 hour (hr), 2,4,6,8,24,48 and 72 hr postdose
ID
Title
Description
OG000
2 mg/m^2/Day LY2523355
2 milligrams per meter squared per day (mg/m^2/day) LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
OG001
4 mg/m^2/Day LY2523355
4 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
OG002
5 mg/m^2/Day LY2523355
5 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
OG003
6 mg/m^2/Day LY2523355
6 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
OG004
7 mg/m^2/Day LY2523355
7 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
OG005
8 mg/m^2/Day LY2523355
8 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion across all schedules and in the presence or absence of PEG administered subcutaneously.
OG006
12 mg/m^2/Day LY2523355
12 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6 and on Days 1 and 4 of 21-day cycle plus PEG administered subcutaneously on Day 5.
OG007
14 mg/m^2/Day LY2523355
14 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
OG008
16 mg/m^2/Day LY2523355
16 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
AUC(0-∞)
Title
Measurements
OG000172± 34
OG001377± 73
OG002718± 52
OG003
Secondary
Number of Participants With Tumor Response
Response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST) criteria and the Revised International Working Group (IWG) lymphoma response criteria for lymphoma patients. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir. Tumor response is CR + PR.
All participants who received 1 dose of LY2523355.
Posted
Number
90% Confidence Interval
participants
Baseline to measured disease progression or discontinuation up to Cycle 38 (21-day cycles)
ID
Title
Description
OG000
LY2523355 Days 1, 5 and 9
Escalating dose started at 2 milligrams per meter squared (mg/m^2) LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5 and 9, for two planned cycles of 21 days. Dose could be escalated by a maximum increment of the lesser of doubling the current dose or 4 milligrams per meter squared per day (mg/m^2/day), with a maximum allowed dose of 30 mg/m^2/day. Participants continued on study drug until disease progression, unacceptable toxicity or other withdrawal criterion were met up to 38 cycles of 21 days.
OG001
LY2523355 Days 1 and 8
Escalating dose started at 8 mg/m^2 of LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 8 for two planned 21-day cycles. Dose could be escalated by a maximum of 4 mg/m^2/day, with a maximum allowed dose of 30 mg/m^2/day. Participants continued on study drug until disease progression, unacceptable toxicity or other withdrawal criterion were met up to 38 cycles of 21-days.
OG002
LY2523355 Days 1 and 5 + PEG
Escalating dose started at 8 mg/m^2 LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5, for two planned cycles of 21-days and 6 mg pegfilgrastim (PEG) administered subcutaneously on Day 6 of each 21-day cycle for the 2 planned cycles and for any subsequent cycles of LY2523355 received. Dose could be escalated by a maximum of 4 mg/m^2/day, with a maximum allowed dose of 30 mg/m^2/day. Participants continued on study drug until disease progression, unacceptable toxicity or other withdrawal criterion were met up to 38 cycles of 21-days.
OG003
LY2523355 Days 1 and 4 + PEG
12 mg/m^2 LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 4, for two planned 21 days cycles, 6 mg PEG administered subcutaneously on Day 5 of each 21-day cycle for the 2 planned cycles and for any subsequent cycles of LY2523355 received. Participants continued on study drug until disease progression, unacceptable toxicity or other withdrawal criterion were met up to 38 cycles of 21-days.
Units
Counts
Participants
OG00027
OG0016
OG00224
OG003
Title
Denominators
Categories
Title
Measurements
OG0000(0 to 0)
OG0010(0 to 0)
OG0020(0 to 0)
OG003
1
3
3
3
EG001
Part A - Days 1, 5, 9 - 4 mg/m^2/Day
Part A (Dose Escalation Phase): 4 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
2
3
2
3
EG002
Part A - Days 1, 5, 9 - 8 mg/m^2/Day
Part A (Dose Escalation Phase): 8 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
2
6
6
6
EG003
Part A - Days 1, 5, 9 - 7 mg/m^2/Day
Part A (Dose Escalation Phase): 7 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
2
6
6
6
EG004
Part A - Days 1, 5, 9 - 6 mg/m^2/Day
Part A (Dose Escalation Phase): 6 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
1
6
6
6
EG005
Part A - Days 1, 5, 9 - 5 mg/m^2/Day
Part A (Dose Escalation Phase): 5 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
0
3
3
3
EG006
Part A - Days 1, 8 - 8 mg/m^2/Day
Part A (Dose Escalation Phase): 8 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 8 of 21-day cycle.
1
6
6
6
EG007
Part A - Days 1, 5+PEG - 8 mg/m^2/Day
Part A (Dose Escalation Phase): 8 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus pegfilgrastim (PEG) administered subcutaneously on Day 6.
0
3
3
3
EG008
Part A - Days 1, 5+PEG - 12 mg/m^2/Day
Part A (Dose Escalation Phase): 12 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
0
3
3
3
EG009
Part A - Days 1, 5+PEG - 16 mg/m^2/Day
Part A (Dose Escalation Phase): 16 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
3
4
4
4
EG010
Part A - Days 1, 5+PEG - 14 mg/m^2/Day
Part A (Dose Escalation Phase): 14 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
2
4
4
4
EG011
Part B - Days 1, 5+PEG - 12 mg/m^2/Day
Part B (Dose Maintenance Phase): 12 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
4
10
10
10
EG012
Part B - Days 1, 4+PEG - 12 mg/m^2/d
Part B (Dose Maintenance Phase): 12 mg/m^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 4 of 21-day cycle plus PEG administered subcutaneously Day 5.
4
6
6
6
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected4 at risk
EG0100 events0 affected4 at risk
EG0111 events1 affected10 at risk
EG0121 events1 affected6 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0101 events1 affected4 at risk
EG0111 events1 affected10 at risk
EG0120 events0 affected6 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0101 events1 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0121 events1 affected6 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Nausea
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Pancreatitis
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0121 events1 affected6 at risk
Proctitis
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0111 events1 affected10 at risk
EG0120 events0 affected6 at risk
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0121 events1 affected6 at risk
Vomiting
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Asthenia
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Mucosal inflammation
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0111 events1 affected10 at risk
EG0120 events0 affected6 at risk
Oedema
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0121 events1 affected6 at risk
Pyrexia
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected4 at risk
EG0101 events1 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Neutropenic sepsis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected4 at risk
EG0101 events1 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Perirectal abscess
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Pneumonia
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0111 events1 affected10 at risk
EG0121 events1 affected6 at risk
Sepsis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Cerebrovascular accident
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Mental status changes
Psychiatric disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0032 events2 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0121 events1 affected6 at risk
Angioedema
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0111 events1 affected10 at risk
EG0120 events0 affected6 at risk
Deep vein thrombosis
Vascular disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected6 at risk
EG0031 events1 affected6 at risk
EG0042 events2 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0072 events2 affected3 at risk
EG0082 events2 affected3 at risk
EG0091 events1 affected4 at risk
EG0101 events1 affected4 at risk
EG0114 events4 affected10 at risk
EG0123 events3 affected6 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0023 events3 affected6 at risk
EG0034 events4 affected6 at risk
EG0045 events5 affected6 at risk
EG0052 events2 affected3 at risk
EG0065 events5 affected6 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected3 at risk
EG0090 events0 affected4 at risk
EG0101 events1 affected4 at risk
EG0111 events1 affected10 at risk
EG0123 events3 affected6 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected4 at risk
EG0101 events1 affected4 at risk
EG0110 events0 affected10 at risk
EG0122 events2 affected6 at risk
Tachycardia
Cardiac disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Ear pain
Ear and labyrinth disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0111 events1 affected10 at risk
EG0120 events0 affected6 at risk
Tinnitus
Ear and labyrinth disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Blindness
Eye disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0101 events1 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Dry eye
Eye disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0121 events1 affected6 at risk
Vision blurred
Eye disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0121 events1 affected6 at risk
Visual impairment
Eye disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0101 events1 affected4 at risk
EG0110 events0 affected10 at risk
EG0121 events1 affected6 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected4 at risk
EG0100 events0 affected4 at risk
EG0111 events1 affected10 at risk
EG0121 events1 affected6 at risk
Anorectal discomfort
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Aphthous stomatitis
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0121 events1 affected6 at risk
Constipation
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0023 events3 affected6 at risk
EG0032 events2 affected6 at risk
EG0044 events4 affected6 at risk
EG0051 events1 affected3 at risk
EG0062 events2 affected6 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected3 at risk
EG0092 events2 affected4 at risk
EG0100 events0 affected4 at risk
EG0111 events1 affected10 at risk
EG0123 events3 affected6 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected3 at risk
EG0063 events3 affected6 at risk
EG0071 events1 affected3 at risk
EG0082 events2 affected3 at risk
EG0091 events1 affected4 at risk
EG0100 events0 affected4 at risk
EG0113 events3 affected10 at risk
EG0122 events2 affected6 at risk
Dry mouth
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0111 events1 affected10 at risk
EG0120 events0 affected6 at risk
Dysphagia
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected4 at risk
EG0101 events1 affected4 at risk
EG0112 events2 affected10 at risk
EG0120 events0 affected6 at risk
Haematochezia
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Haemorrhoids
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0111 events1 affected10 at risk
EG0120 events0 affected6 at risk
Lip swelling
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Mucous stools
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Nausea
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected6 at risk
EG0032 events2 affected6 at risk
EG0042 events2 affected6 at risk
EG0051 events1 affected3 at risk
EG0063 events3 affected6 at risk
EG0070 events0 affected3 at risk
EG0082 events2 affected3 at risk
EG0091 events1 affected4 at risk
EG0101 events1 affected4 at risk
EG0113 events3 affected10 at risk
EG0123 events3 affected6 at risk
Oesophagitis
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Oral pain
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0101 events1 affected4 at risk
EG0111 events1 affected10 at risk
EG0120 events0 affected6 at risk
Proctalgia
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0111 events1 affected10 at risk
EG0120 events0 affected6 at risk
Stomatitis
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0112 events2 affected10 at risk
EG0120 events0 affected6 at risk
Swollen tongue
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Vomiting
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG0032 events2 affected6 at risk
EG0043 events3 affected6 at risk
EG0051 events1 affected3 at risk
EG0062 events2 affected6 at risk
EG0071 events1 affected3 at risk
EG0081 events1 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0113 events3 affected10 at risk
EG0123 events3 affected6 at risk
Asthenia
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected4 at risk
EG0101 events1 affected4 at risk
EG0112 events2 affected10 at risk
EG0121 events1 affected6 at risk
Catheter site pain
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Chest pain
General disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Chills
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected4 at risk
EG0101 events1 affected4 at risk
EG0110 events0 affected10 at risk
EG0121 events1 affected6 at risk
Early satiety
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Face oedema
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Facial pain
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0111 events1 affected10 at risk
EG0120 events0 affected6 at risk
Fatigue
General disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0024 events4 affected6 at risk
EG0031 events1 affected6 at risk
EG0043 events3 affected6 at risk
EG0053 events3 affected3 at risk
EG0065 events5 affected6 at risk
EG0070 events0 affected3 at risk
EG0082 events2 affected3 at risk
EG0092 events2 affected4 at risk
EG0101 events1 affected4 at risk
EG0117 events7 affected10 at risk
EG0122 events2 affected6 at risk
Feeling cold
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0111 events1 affected10 at risk
EG0120 events0 affected6 at risk
Gait disturbance
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0111 events1 affected10 at risk
EG0121 events1 affected6 at risk
Injection site pruritus
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0101 events1 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Mucosal inflammation
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected3 at risk
EG0092 events2 affected4 at risk
EG0100 events0 affected4 at risk
EG0114 events4 affected10 at risk
EG0121 events1 affected6 at risk
Oedema
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0101 events1 affected4 at risk
EG0110 events0 affected10 at risk
EG0121 events1 affected6 at risk
Oedema peripheral
General disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0082 events2 affected3 at risk
EG0090 events0 affected4 at risk
EG0101 events1 affected4 at risk
EG0111 events1 affected10 at risk
EG0120 events0 affected6 at risk
Pain
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected4 at risk
EG0100 events0 affected4 at risk
EG0113 events3 affected10 at risk
EG0120 events0 affected6 at risk
Pyrexia
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG0032 events2 affected6 at risk
EG0041 events1 affected6 at risk
EG0051 events1 affected3 at risk
EG0061 events1 affected6 at risk
EG0071 events1 affected3 at risk
EG0082 events2 affected3 at risk
EG0091 events1 affected4 at risk
EG0100 events0 affected4 at risk
EG0114 events4 affected10 at risk
EG0122 events2 affected6 at risk
Temperature intolerance
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0121 events1 affected6 at risk
Ulcer
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Cholelithiasis
Hepatobiliary disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Hypersensitivity
Immune system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0111 events1 affected10 at risk
EG0120 events0 affected6 at risk
Bronchitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Candidiasis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0111 events1 affected10 at risk
EG0120 events0 affected6 at risk
Central line infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Diverticulitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Fungal infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0121 events1 affected6 at risk
Fungal skin infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0111 events1 affected10 at risk
EG0120 events0 affected6 at risk
Genital infection fungal
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0111 events1 affected10 at risk
EG0120 events0 affected6 at risk
Onychomycosis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Pharyngitis streptococcal
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Pneumonia
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0101 events1 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Post procedural infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0121 events1 affected6 at risk
Respiratory tract infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Rhinitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Urinary tract infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0111 events1 affected10 at risk
EG0120 events0 affected6 at risk
Viral infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Fall
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0101 events1 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Thermal burn
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0111 events1 affected10 at risk
EG0120 events0 affected6 at risk
Blood bilirubin increased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Blood cortisol increased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0101 events1 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Blood creatinine increased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Blood glucose decreased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Blood iron decreased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Blood potassium decreased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Blood potassium increased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Calcium ionised decreased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0101 events1 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Electrocardiogram qt prolonged
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Neutrophil count decreased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0121 events1 affected6 at risk
Prothrombin time ratio increased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Urine output decreased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0101 events1 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Weight decreased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0101 events1 affected4 at risk
EG0112 events2 affected10 at risk
EG0120 events0 affected6 at risk
White blood cell count increased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Anorexia
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0022 events2 affected6 at risk
EG0031 events1 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0092 events2 affected4 at risk
EG0101 events1 affected4 at risk
EG0112 events2 affected10 at risk
EG0120 events0 affected6 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0042 events2 affected6 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0112 events2 affected10 at risk
EG0120 events0 affected6 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected3 at risk
EG0091 events1 affected4 at risk
EG0100 events0 affected4 at risk
EG0111 events1 affected10 at risk
EG0123 events3 affected6 at risk
Gout
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0121 events1 affected6 at risk
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected4 at risk
EG0100 events0 affected4 at risk
EG0111 events1 affected10 at risk
EG0120 events0 affected6 at risk
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0023 events3 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected3 at risk
EG0062 events2 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0112 events2 affected10 at risk
EG0121 events1 affected6 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected3 at risk
EG0090 events0 affected4 at risk
EG0102 events2 affected4 at risk
EG0111 events1 affected10 at risk
EG0121 events1 affected6 at risk
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0101 events1 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Limb discomfort
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0101 events1 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0111 events1 affected10 at risk
EG0120 events0 affected6 at risk
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0101 events1 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0101 events1 affected4 at risk
EG0111 events1 affected10 at risk
EG0120 events0 affected6 at risk
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0111 events1 affected10 at risk
EG0120 events0 affected6 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0111 events1 affected10 at risk
EG0120 events0 affected6 at risk
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected6 at risk
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)