A Study of Durvalumab or Tremelimumab Monotherapy, or Dur... | NCT02519348 | Trialant
NCT02519348
Sponsor
MedImmune LLC
Status
Active, not recruiting
Last Update Posted
Jun 3, 2026Actual
Enrollment
433Actual
Phase
Phase 2
Conditions
Hepatocellular Carcinoma
Interventions
Tremelimumab
Durvalumab
Bevacizumab
Countries
United States
China
Hong Kong
Italy
Japan
Singapore
South Korea
Spain
Taiwan
Protocol Section
Identification Module
NCT ID
NCT02519348
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
D4190C00022
Secondary IDs
ID
Type
Description
Link
2024-517085-41-00
Registry Identifier
CTIS
2015-001663-39
EudraCT Number
Brief Title
A Study of Durvalumab or Tremelimumab Monotherapy, or Durvalumab in Combination With Tremelimumab or Bevacizumab in Advanced Hepatocellular Carcinoma
Official Title
A Study of Safety, Tolerability, and Clinical Activity of Durvalumab and Tremelimumab Administered as Monotherapy, or Durvalumab in Combination With Tremelimumab or Bevacizumab in Subjects With Advanced Hepatocellular Carcinoma
Acronym
Not provided
Organization
MedImmune LLCINDUSTRY
Status Module
Record Verification Date
May 2026
Overall Recruitment Status or Expanded Access Status
Active, not recruiting
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 19, 2015Actual
Primary Completion Date
Nov 6, 2020Actual
Completion Date
Dec 18, 2026Estimated
First Submitted Date
Jul 30, 2015
First Submission Date that Met QC Criteria
Aug 5, 2015
First Posted Date
Aug 10, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 5, 2021
Results First Submitted that Met QC Criteria
Nov 5, 2021
Results First Posted Date
Dec 6, 2021Actual
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
May 8, 2026
Last Update Posted Date
Jun 3, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
MedImmune LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a multicenter, open-label, stratified, randomized study to evaluate the safety, tolerability, antitumor activity, pharmacokinetics, pharmacodynamics, and immunogenicity of durvalumab or tremelimumab monotherapy, or durvalumab in combination with tremelimumab or bevacizumab in advanced hepatocellular carcinoma.
Detailed Description
The study will comprise of 6 parts. Participants in Part 1A (safety run-in cohort), Part 1B (efficacy-gating cohort), Part 2A, and Part 4 will receive weight-based dosing regimens; and participants in Part 2B and Part 3 will receive fixed dosing regimens. Part 1A Stage 2 of the study may start after the first 3 participants in Stage 1 have been observed on study for at least 4 weeks. In addition, a separate cohort of participants will be enrolled in mainland China (China cohort) once global recruitment in Part 2A will be closed.
In Part 1 (both 1A and 1B), participants will receive tremelimumab 1 mg/kg intravenous (IV) every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W.
In Part 2A, participants will be randomized in a 1:1:1 ratio to receive:
Durvalumab 20 mg/kg Q4W
Tremelimumab 10 mg/kg Q4W × 7 doses followed by every 12 weeks (Q12W)
Tremelimumab 1 mg/kg Q4W × 4 doses + durvalumab 20 mg/kg Q4W, followed by durvalumab 20 mg/kg Q4W
In China cohort, Part 2A study design will be followed.
In Part 2B, participants will receive tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W.
In Part 3, participants will be randomized in a 2:2:1:2 ratio to receive:
Tremelimumab 750 mg Q4W for 7 doses followed by Q12W
Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W, followed by durvalumab 1500 mg Q4W.
Following protocol amendment 5, enrollment into 'Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg' arm will close. Participants will be randomized at a ratio of 2:1:2 in 'Durvalumab 1500 mg Q4W', 'Tremelimumab 750 mg Q4W for 7 doses followed by Q12W', and 'Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W' arms, respectively.
• In Part 4, participants will receive durvalumab 1120 mg (15 mg/kg) + bevacizumab 15 mg/kg every 3 weeks (Q3W).
Participants will receive the treatment until confirm progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first.
All participants will be followed for survival until the end of study visit (last participant discontinues the study treatment).
Conditions Module
Conditions
Hepatocellular Carcinoma
Keywords
Hepatocellular Carcinoma
Immunotherapy
Antibodies, Monoclonal
Tremelimumab
MEDI4736
Durvalumab
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
433Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg
Experimental
Participants in Part 1A (safety run-in cohort) and Part 1 B (efficacy-gating cohort) will receive tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first.
Biological: Tremelimumab
Biological: Durvalumab
Parts 2 and 3: Durvalumab 1500 mg
Experimental
Participants will receive durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first.
Biological: Durvalumab
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg
Experimental
Participants will receive tremelimumab 300 mg 1 dose and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow, or development of other reason for treatment discontinuation, whichever occurs first.
Biological: Tremelimumab
Biological: Durvalumab
Parts 2 and 3: Tremelimumab 750 mg
Experimental
Participants will receive tremelimumab 750 mg Q4W 7 doses followed by every 12 weeks (Q12W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Tremelimumab
Biological
Tremelimumab will be administered by IV infusion according to doses and frequency mentioned in arms' description.
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose Limiting Toxicities (DLTs)
A DLT was defined as treatment-related toxicity that occurred during DLT evaluation period including: any Grade 4 immune-related adverse event (irAE), any Grade 3 colitis or any Grade 3 noninfectious pneumonitis irrespective of duration, any >= Grade 2 pneumonitis that does not resolve to <= Grade 1 within 7 days of initiation of maximal supportive care, any other Grade 3 irAE (excluding colitis or pneumonitis) that does not downgrade to Grade 2 within 7 days after onset of the event despite optimal medical management including systemic corticosteroids or does not downgrade to <= Grade 1 or baseline within 14 days, liver transaminase elevation > 8 × upper limit of normal (ULN) or total bilirubin > 5 × ULN, aspartate aminotransferase or alanine aminotransferase > 3 × ULN with concurrent increase in total bilirubin > 2 × ULN without evidence of cholestasis or alternative explanations, and any >= Grade 3 non-irAE (except for the protocol stated conditions).
From Day 1 to Day 28 after first dose of study drug
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. There will be no updated results for this outcome measure at the time of end of study.
From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)
Number of Participants With Clinically Important Changes in Hematology and Clinical Chemistry Parameters
Participants with clinically important Common Terminology Criteria for Adverse Events (CTCAE) grade changes to 3 or 4 in hematology and chemistry parameters are reported. There will be no updated results for this outcome measure at the time of end of study.
Secondary Outcomes
Measure
Description
Time Frame
Overall Objective Response Rate (ORR) Based on Investigator Assessments and Blinded Independent Central Review (BICR)
Disease assessments based on investigator assessments and BICR review were determined by using Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) guidelines. The ORR is defined as best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR). The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as >= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion. A confirmed CR or PR is defined as 2 CRs or 2 PRs that were separated by at least 4 weeks with no evidence of progression in-between. There will be no updated results for this outcome measure at the time of end of study.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female participants
18 years and older (Japan-20 years and older)
Confirmed hepatocellular carcinoma (HCC) based on histopathological findings from tumor tissues. Advanced HCC with diagnosis confirmed pathologically or with noninvasive methods.
Immunotherapy-naïve
Have either progressed on, are intolerant to, or refused treatment with sorafenib or another approved TKI. For arm 5 only: Have not received any prior systemic therapy for HCC.
Exclusion Criteria:
Prior exposure to immune-mediated therapy
Hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy
Gastrointestinal bleeding (eg, esophageal varices or ulcer bleeding) within 12 months
Ascites requiring non-pharmacologic intervention (eg, paracentesis) to maintain symptomatic control, within 6 months prior to the first scheduled dose.
Main portal vein thrombosis (Vp4) as documented on imaging
Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment
Active or prior documented autoimmune or inflammatory disease with some exceptions
Current or prior use of immunosuppressive medication within 14 days with some exceptions
Kelley RK, Sangro B, Harris W, Ikeda M, Okusaka T, Kang YK, Qin S, Tai DW, Lim HY, Yau T, Yong WP, Cheng AL, Gasbarrini A, Damian S, Bruix J, Borad M, Bendell J, Kim TY, Standifer N, He P, Makowsky M, Negro A, Kudo M, Abou-Alfa GK. Safety, Efficacy, and Pharmacodynamics of Tremelimumab Plus Durvalumab for Patients With Unresectable Hepatocellular Carcinoma: Randomized Expansion of a Phase I/II Study. J Clin Oncol. 2021 Sep 20;39(27):2991-3001. doi: 10.1200/JCO.20.03555. Epub 2021 Jul 22.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
The results data are reported per the primary completion date (data cut-off date of 06Nov2020).
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg
Participants in Part 1A (safety run-in cohort) and Part 1 B (efficacy-gating cohort) received tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jan 4, 2019
Nov 25, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
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
Biological: Tremelimumab
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg
Experimental
Participants will receive tremelimumab 75 mg Q4W 4 doses and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first. Participant recruitment to this arm was closed following protocol amendment 5.
Biological: Tremelimumab
Biological: Durvalumab
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg
Experimental
Participants will receive durvalumab 1120 mg and bevacizumab 15 mg/kg every 3 weeks (Q3W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first
Biological: Durvalumab
Biological: Bevacizumab
China Cohort: Durvalumab 20 mg/kg
Experimental
Participants will receive durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first.
Biological: Durvalumab
China Cohort: Tremelimumab 10 mg/kg
Experimental
Participants will receive tremelimumab 10 mg/kg Q4W 7 doses followed by Q12W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first.
Biological: Tremelimumab
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg
Experimental
Participants will receive tremelimumab 1 mg/kg Q4W 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first.
Biological: Tremelimumab
Biological: Durvalumab
China Cohort: Tremelimumab 10 mg/kg
Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg
Parts 2 and 3: Tremelimumab 750 mg
Durvalumab
Biological
Durvalumab will be administered by IV infusion according to doses and frequency mentioned in arms' description.
China Cohort: Durvalumab 20 mg/kg
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg
Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg
Parts 2 and 3: Durvalumab 1500 mg
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg
MEDI4736
Bevacizumab
Biological
Bevacizumab 15 mg/kg will be administered by IV infusion every 3 weeks until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg
From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)
Number of Participants With Abnormal Vital Signs Reported as TEAEs
Vital sign assessment included pulse rate, blood pressure, temperature, weight, and respiratory rate. Vital signs abnormalities recorded as TEAEs are reported. There will be no updated results for this outcome measure at the time of end of study.
From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)
Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse Events
Number of participants with ECG abnormalities recorded as TEAEs are reported. There will be no updated results for this outcome measure at the time of end of study.
From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)
From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)
Disease Control Rate (DCR) Based on Investigator Assessments and BICR
Disease assessments based on investigator assessments and BICR review were determined by using RECIST v1.1 guidelines. The DCR is defined as a BOR of confirmed CR, confirmed PR, or stable disease (SD). A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as two PRs (>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) that were separated by at least 4 weeks with no evidence of progression in-between. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. There will be no updated results for this outcome measure at the time of end of study.
From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)
Time to Response (TTR) Based on Investigator Assessments and BICR
Disease assessments based on investigator assessments and BICR review were determined by using RECIST v1.1 guidelines. The TTR is defined as the time from randomization for Parts 2A and 3, and time from first dose for Parts 1, 2B, and 4 until the first documentation of a subsequently confirmed OR (confirmed CR or confirmed PR). A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as two PRs (>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) that were separated by at least 4 weeks with no evidence of progression in-between. The TTR was estimated using Kaplan-Meier method. There will be no updated results for this outcome measure at the time of end of study.
From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)
Duration of Response (DoR) Based on Investigator Assessments and BICR
The DoR is defined as the time from the date of first documented OR (confirmed CR or confirmed PR) until date of documented progression (PD) based on investigator assessments and BICR review by using RECIST v1.1 or death in absence of disease progression. A confirmed CR is defined in above outcome measures. The PD is defined at least 20% increase in sum of diameters of target lesions (compared with nadir at 2 consecutive visits with an absolute increase of 5 mm), unequivocal progression of existing non-target lesions or new lesion. For participants who were alive and no documented PD at the time of data cutoff for analysis, DoR was censored at the last evaluable disease assessment date. The DoR was estimated using Kaplan-Meier method. There will be no updated results for this outcome measure at the time of end of study.
From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)
Time to Progression (TTP) Based on Investigator Assessments and BICR
Disease assessments based on investigator assessments and BICR review were determined by using RECIST v1.1 guidelines. The TTP was defined as the time from randomization for Parts 2A and 3, and time from first dose for Parts 1, 2B, and 4 to the first documentation of radiographic disease progression. However, if the participant died without tumor progression, they were censored at the time of death. Participants with no documented PD by the data cutoff date for TTP analysis were censored at the date of their last evaluable disease assessment. The TTP was estimated using Kaplan-Meier method. There will be no updated results for this outcome measure at the time of end of study.
From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)
Progression Free Survival (PFS) Based on Investigator Assessments and BICR
Disease assessments based on investigator assessments and BICR review were determined by using RECIST v1.1 guidelines. The PFS is defined as the time from randomization for Parts 2A and 3, and time from first dose for Parts 1, 2B, and 4 until the first documentation of radiographic disease progression or death due to any cause, whichever occurs first. The PD is defined at least 20% increase in the sum of diameters of target lesions (compared with the nadir at 2 consecutive visits with an absolute increase of 5 mm), unequivocal progression of existing non-target lesions or new lesion. Participants who were alive with no documented PD by the data cutoff date for PFS analysis were censored at the date of their last evaluable disease assessment. The PFS was estimated using Kaplan-Meier method. There will be no updated results for this outcome measure at the time of end of study.
From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)
Overall Survival (OS)
The OS is defined as the time from randomization for Parts 2A and 3, and time from first dose for Parts 1, 2B, and 4 until death due to any cause. If there was no death reported for a participant by the data cut-off date for overall survival analysis, OS was censored at the last known alive date. The OS was estimated using Kaplan-Meier method. There will be no updated results for this outcome measure at the time of end of study.
From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)
Participants received durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
FG002
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg
Participants received tremelimumab 300 mg 1 dose and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow, or development of other reason for treatment discontinuation, whichever occurred first.
FG003
Parts 2 and 3: Tremelimumab 750 mg
Participants received tremelimumab 750 mg Q4W 7 doses followed by every 12 weeks (Q12W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
FG004
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg
Participants received tremelimumab 75 mg Q4W 4 doses and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
FG005
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg
Participants received durvalumab 1120 mg and bevacizumab 15 mg/kg every 3 weeks (Q3W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
FG006
China Cohort: Durvalumab 20 mg/kg
Participants received durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
FG007
China Cohort: Tremelimumab 10 mg/kg
Participants received tremelimumab 10 mg/kg Q4W 7 doses followed by Q12W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
FG008
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg
Participants received tremelimumab 1 mg/kg Q4W 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
FG00040 subjects
FG001104 subjects
FG00275 subjects
FG00369 subjects
FG00484 subjects
FG00547 subjects
FG0063 subjects
FG0075 subjects
FG0086 subjects
Treated
FG00040 subjects
FG001101 subjects
FG00274 subjects
FG00369 subjects
FG00482 subjects
FG00547 subjects
FG0063 subjects
FG0075 subjects
FG0085 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
NOT COMPLETED
FG00040 subjects
FG001104 subjects
FG00275 subjects
FG00369 subjects
FG00484 subjects
FG00547 subjects
FG0063 subjects
FG0075 subjects
FG0086 subjects
Type
Comment
Reasons
Death
FG00031 subjects
FG00174 subjects
FG00247 subjects
FG00354 subjects
FG00463 subjects
FG00518 subjects
FG0062 subjects
FG0075 subjects
FG0085 subjects
Withdrawal by Subject
FG0004 subjects
FG0017 subjects
FG0024 subjects
FG0033 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
FG004
Ongoing at the time of data cut-off date
FG0005 subjects
FG00120 subjects
FG00223 subjects
FG00312 subjects
Full analysis set included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1A, 1B, 2B, and 4), including participants who were randomized in error.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg
Participants in Part 1A (safety run-in cohort) and Part 1 B (efficacy-gating cohort) received tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
BG001
Parts 2 and 3: Durvalumab 1500 mg
Participants received durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
BG002
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg
Participants received tremelimumab 300 mg 1 dose and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow, or development of other reason for treatment discontinuation, whichever occurred first.
BG003
Parts 2 and 3: Tremelimumab 750 mg
Participants received tremelimumab 750 mg Q4W 7 doses followed by every 12 weeks (Q12W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
BG004
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg
Participants received tremelimumab 75 mg Q4W 4 doses and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
BG005
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg
Participants received durvalumab 1120 mg and bevacizumab 15 mg/kg every 3 weeks (Q3W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
BG006
China Cohort: Durvalumab 20 mg/kg
Participants received durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
BG007
China Cohort: Tremelimumab 10 mg/kg
Participants received tremelimumab 10 mg/kg Q4W 7 doses followed by Q12W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
BG008
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg
Participants received tremelimumab 1 mg/kg Q4W 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00040
BG001104
BG00275
BG00369
BG00484
BG00547
BG0063
BG0075
BG0086
BG009433
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
< 65 years
BG00027
BG00152
BG00234
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00010
BG00112
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0002
BG0015
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0001
BG0011
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Dose Limiting Toxicities (DLTs)
A DLT was defined as treatment-related toxicity that occurred during DLT evaluation period including: any Grade 4 immune-related adverse event (irAE), any Grade 3 colitis or any Grade 3 noninfectious pneumonitis irrespective of duration, any >= Grade 2 pneumonitis that does not resolve to <= Grade 1 within 7 days of initiation of maximal supportive care, any other Grade 3 irAE (excluding colitis or pneumonitis) that does not downgrade to Grade 2 within 7 days after onset of the event despite optimal medical management including systemic corticosteroids or does not downgrade to <= Grade 1 or baseline within 14 days, liver transaminase elevation > 8 × upper limit of normal (ULN) or total bilirubin > 5 × ULN, aspartate aminotransferase or alanine aminotransferase > 3 × ULN with concurrent increase in total bilirubin > 2 × ULN without evidence of cholestasis or alternative explanations, and any >= Grade 3 non-irAE (except for the protocol stated conditions).
DLT evaluable set included all Part 1A participants who received at least 1 dose of study drug and completed the safety follow-up through the DLT evaluation period (Days 1 to 28 after first dose of study drug) or experienced any DLT.
Posted
Count of Participants
Participants
From Day 1 to Day 28 after first dose of study drug
ID
Title
Description
OG000
Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg
Participants in Part 1A (safety run-in cohort) received tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Units
Counts
Participants
OG00016
Title
Denominators
Categories
Title
Measurements
OG0000
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. There will be no updated results for this outcome measure at the time of end of study.
Safety analysis set included all participants who received at least one dose of study drug.
Posted
Count of Participants
Participants
From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)
ID
Title
Description
OG000
Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg
Participants in Part 1A (safety run-in cohort) and Part 1 B (efficacy-gating cohort) received tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG001
Primary
Number of Participants With Clinically Important Changes in Hematology and Clinical Chemistry Parameters
Participants with clinically important Common Terminology Criteria for Adverse Events (CTCAE) grade changes to 3 or 4 in hematology and chemistry parameters are reported. There will be no updated results for this outcome measure at the time of end of study.
Safety analysis set included all participants who received at least one dose of study drug. 'Number of participants analyzed' denotes only those participants for whom hematological and clinical chemistry parameter were analyzed. 'Number Analyzed' denotes the participants analyzed for the specified laboratory parameter.
Posted
Count of Participants
Participants
From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)
ID
Title
Description
OG000
Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg
Participants in Part 1A (safety run-in cohort) and Part 1 B (efficacy-gating cohort) received tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG001
Parts 2 and 3: Durvalumab 1500 mg
Participants received durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Primary
Number of Participants With Abnormal Vital Signs Reported as TEAEs
Vital sign assessment included pulse rate, blood pressure, temperature, weight, and respiratory rate. Vital signs abnormalities recorded as TEAEs are reported. There will be no updated results for this outcome measure at the time of end of study.
Safety analysis set included all participants who received at least one dose of study drug.
Posted
Count of Participants
Participants
From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)
ID
Title
Description
OG000
Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg
Participants in Part 1A (safety run-in cohort) and Part 1 B (efficacy-gating cohort) received tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG001
Parts 2 and 3: Durvalumab 1500 mg
Participants received durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG002
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg
Primary
Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse Events
Number of participants with ECG abnormalities recorded as TEAEs are reported. There will be no updated results for this outcome measure at the time of end of study.
Safety analysis set included all participants who received at least one dose of study drug.
Posted
Count of Participants
Participants
From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)
ID
Title
Description
OG000
Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg
Participants in Part 1A (safety run-in cohort) and Part 1 B (efficacy-gating cohort) received tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG001
Parts 2 and 3: Durvalumab 1500 mg
Participants received durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG002
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg
Secondary
Overall Objective Response Rate (ORR) Based on Investigator Assessments and Blinded Independent Central Review (BICR)
Disease assessments based on investigator assessments and BICR review were determined by using Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) guidelines. The ORR is defined as best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR). The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as >= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion. A confirmed CR or PR is defined as 2 CRs or 2 PRs that were separated by at least 4 weeks with no evidence of progression in-between. There will be no updated results for this outcome measure at the time of end of study.
Full analysis set included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. Analysis of disease assessments based on BICR for Part 1 and China cohorts were not planned and hence not performed.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)
ID
Title
Description
OG000
Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg
Participants in Part 1A (safety run-in cohort) and Part 1 B (efficacy-gating cohort) received tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Secondary
Disease Control Rate (DCR) Based on Investigator Assessments and BICR
Disease assessments based on investigator assessments and BICR review were determined by using RECIST v1.1 guidelines. The DCR is defined as a BOR of confirmed CR, confirmed PR, or stable disease (SD). A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as two PRs (>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) that were separated by at least 4 weeks with no evidence of progression in-between. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. There will be no updated results for this outcome measure at the time of end of study.
Full analysis set included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. Analysis of disease assessments based on BICR for Part 1 and China cohorts were not planned and hence not performed.
Posted
Number
Percentage of participants
From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)
ID
Title
Description
OG000
Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg
Participants in Part 1A (safety run-in cohort) and Part 1 B (efficacy-gating cohort) received tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Secondary
Time to Response (TTR) Based on Investigator Assessments and BICR
Disease assessments based on investigator assessments and BICR review were determined by using RECIST v1.1 guidelines. The TTR is defined as the time from randomization for Parts 2A and 3, and time from first dose for Parts 1, 2B, and 4 until the first documentation of a subsequently confirmed OR (confirmed CR or confirmed PR). A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as two PRs (>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) that were separated by at least 4 weeks with no evidence of progression in-between. The TTR was estimated using Kaplan-Meier method. There will be no updated results for this outcome measure at the time of end of study.
Full analysis set included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. Analysis of disease assessments based on BICR for Part 1 and China cohorts were not planned and hence not performed. The TTR was analyzed for participants who achieved OR per BICR and/or investigator assessments. 'Number Analyzed' denotes participants who achieved OR.
Posted
Median
Inter-Quartile Range
Months
From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)
ID
Title
Description
OG000
Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg
Participants in Part 1A (safety run-in cohort) and Part 1 B (efficacy-gating cohort) received tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Secondary
Duration of Response (DoR) Based on Investigator Assessments and BICR
The DoR is defined as the time from the date of first documented OR (confirmed CR or confirmed PR) until date of documented progression (PD) based on investigator assessments and BICR review by using RECIST v1.1 or death in absence of disease progression. A confirmed CR is defined in above outcome measures. The PD is defined at least 20% increase in sum of diameters of target lesions (compared with nadir at 2 consecutive visits with an absolute increase of 5 mm), unequivocal progression of existing non-target lesions or new lesion. For participants who were alive and no documented PD at the time of data cutoff for analysis, DoR was censored at the last evaluable disease assessment date. The DoR was estimated using Kaplan-Meier method. There will be no updated results for this outcome measure at the time of end of study.
Full analysis set included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. Analysis of disease assessments based on BICR for Part 1 and China cohorts were not planned and hence not performed. The DoR was analyzed for participants who achieved OR per BICR and/or investigator assessments. 'Number Analyzed' denotes participants who achieved OR.
Posted
Median
Inter-Quartile Range
Months
From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)
ID
Title
Description
OG000
Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg
Participants in Part 1A (safety run-in cohort) and Part 1 B (efficacy-gating cohort) received tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Secondary
Time to Progression (TTP) Based on Investigator Assessments and BICR
Disease assessments based on investigator assessments and BICR review were determined by using RECIST v1.1 guidelines. The TTP was defined as the time from randomization for Parts 2A and 3, and time from first dose for Parts 1, 2B, and 4 to the first documentation of radiographic disease progression. However, if the participant died without tumor progression, they were censored at the time of death. Participants with no documented PD by the data cutoff date for TTP analysis were censored at the date of their last evaluable disease assessment. The TTP was estimated using Kaplan-Meier method. There will be no updated results for this outcome measure at the time of end of study.
Full analysis set included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. Analysis of disease assessments based on BICR for Part 1 and China cohorts were not planned and hence not performed.
Posted
Median
95% Confidence Interval
Months
From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)
ID
Title
Description
OG000
Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg
Participants in Part 1A (safety run-in cohort) and Part 1 B (efficacy-gating cohort) received tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Secondary
Progression Free Survival (PFS) Based on Investigator Assessments and BICR
Disease assessments based on investigator assessments and BICR review were determined by using RECIST v1.1 guidelines. The PFS is defined as the time from randomization for Parts 2A and 3, and time from first dose for Parts 1, 2B, and 4 until the first documentation of radiographic disease progression or death due to any cause, whichever occurs first. The PD is defined at least 20% increase in the sum of diameters of target lesions (compared with the nadir at 2 consecutive visits with an absolute increase of 5 mm), unequivocal progression of existing non-target lesions or new lesion. Participants who were alive with no documented PD by the data cutoff date for PFS analysis were censored at the date of their last evaluable disease assessment. The PFS was estimated using Kaplan-Meier method. There will be no updated results for this outcome measure at the time of end of study.
Full analysis set included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. Analysis of disease assessments based on BICR for Part 1 and China cohorts were not planned and hence not performed.
Posted
Median
95% Confidence Interval
Months
From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)
ID
Title
Description
OG000
Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg
Participants in Part 1A (safety run-in cohort) and Part 1 B (efficacy-gating cohort) received tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Secondary
Overall Survival (OS)
The OS is defined as the time from randomization for Parts 2A and 3, and time from first dose for Parts 1, 2B, and 4 until death due to any cause. If there was no death reported for a participant by the data cut-off date for overall survival analysis, OS was censored at the last known alive date. The OS was estimated using Kaplan-Meier method. There will be no updated results for this outcome measure at the time of end of study.
Full analysis set included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error.
Posted
Median
95% Confidence Interval
Months
From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)
ID
Title
Description
OG000
Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg
Participants in Part 1A (safety run-in cohort) and Part 1 B (efficacy-gating cohort) received tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG001
Parts 2 and 3: Durvalumab 1500 mg
Participants received durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Time Frame
From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)
Description
All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error.
The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
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 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg
Participants in Part 1A (safety run-in cohort) and Part 1 B (efficacy-gating cohort) received tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
31
40
22
40
37
40
EG001
Parts 2 and 3: Durvalumab 1500 mg
Participants received durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
78
104
45
101
92
101
EG002
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg
Participants received tremelimumab 300 mg 1 dose and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow, or development of other reason for treatment discontinuation, whichever occurred first.
49
75
32
74
73
74
EG003
Parts 2 and 3: Tremelimumab 750 mg
Participants received tremelimumab 750 mg Q4W 7 doses followed by every 12 weeks (Q12W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
55
69
36
69
66
69
EG004
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg
Participants received tremelimumab 75 mg Q4W 4 doses and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
64
84
37
82
80
82
EG005
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg
Participants received durvalumab 1120 mg and bevacizumab 15 mg/kg every 3 weeks (Q3W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
18
47
17
47
45
47
EG006
China Cohort: Durvalumab 20 mg/kg
Participants received durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
2
3
1
3
3
3
EG007
China Cohort: Tremelimumab 10 mg/kg
Participants received tremelimumab 10 mg/kg Q4W 7 doses followed by Q12W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
5
5
3
5
5
5
EG008
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg
Participants received tremelimumab 1 mg/kg Q4W 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
5
6
4
5
5
5
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute myocardial infarction
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG0030 events0 affected69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
Hypophysitis
Endocrine disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Lymphadenitis
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Cardiac failure chronic
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Myocarditis
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Hypopituitarism
Endocrine disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Inappropriate antidiuretic hormone secretion
Endocrine disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0012 events2 affected101 at risk
EG0022 events2 affected74 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0005 events2 affected40 at risk
EG0013 events3 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Autoimmune colitis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Autoimmune pancreatitis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0010 events0 affected101 at risk
EG0025 events4 affected74 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0013 events3 affected101 at risk
EG0022 events2 affected74 at risk
EG003
Duodenal ulcer haemorrhage
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Epigastric discomfort
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Gastric ulcer perforation
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Gastric varices
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Haemoperitoneum
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Haemorrhagic ascites
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Immune-mediated enterocolitis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Inguinal hernia strangulated
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Large intestinal haemorrhage
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Mallory-weiss syndrome
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Mesenteric haematoma
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Oesophageal varices haemorrhage
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0012 events2 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Small intestinal perforation
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0012 events2 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Varices oesophageal
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Asthenia
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Death
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Fatigue
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0021 events1 affected74 at risk
EG003
General physical health deterioration
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Lipogranuloma
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 23.1
Systematic Assessment
EG0002 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Oedema
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Oedema peripheral
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Pyrexia
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0012 events2 affected101 at risk
EG0023 events3 affected74 at risk
EG003
Autoimmune hepatitis
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Biliary obstruction
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Hepatic cirrhosis
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0012 events2 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG00110 events9 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Hepatic haemorrhage
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Hepatorenal syndrome
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Portal vein thrombosis
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Abdominal infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Anorectal infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0002 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Covid-19
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0011 events1 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Dengue fever
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Encephalitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Influenza
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Klebsiella infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Listeria sepsis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Listeriosis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Liver abscess
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Meningitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Peritonitis bacterial
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0012 events2 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0023 events3 affected74 at risk
EG003
Pneumonia mycoplasmal
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Rhinovirus infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Sepsis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0022 events1 affected74 at risk
EG003
Tuberculosis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Ammonia increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0022 events2 affected74 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Lipase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Platelet count decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0022 events2 affected74 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Diabetic metabolic decompensation
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0011 events1 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Bone lesion
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Intracranial tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Liver carcinoma ruptured
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Ovarian adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Tumour rupture
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Cauda equina syndrome
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Depressed level of consciousness
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Haemorrhagic stroke
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Hepatic encephalopathy
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Hyperammonaemic encephalopathy
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Myasthenia gravis
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Seizure
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Subarachnoid haemorrhage
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Anxiety disorder
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0012 events2 affected101 at risk
EG0022 events2 affected74 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Bronchial obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Emphysema
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0011 events1 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Immune-mediated pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0022 events2 affected74 at risk
EG003
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Erythema multiforme
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0022 events2 affected74 at risk
EG003
Hypotension
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Shock haemorrhagic
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0016 events6 affected101 at risk
EG00212 events7 affected74 at risk
EG00313 events10 affected69 at risk
EG00416 events9 affected82 at risk
EG0052 events2 affected47 at risk
EG0061 events1 affected3 at risk
EG0071 events1 affected5 at risk
EG0082 events2 affected5 at risk
Coagulopathy
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0022 events2 affected74 at risk
EG003
Microcytic anaemia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0005 events2 affected40 at risk
EG0012 events2 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Atrioventricular block first degree
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Cerumen impaction
Ear and labyrinth disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Adrenocorticotropic hormone deficiency
Endocrine disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0012 events2 affected101 at risk
EG0026 events6 affected74 at risk
EG003
Hypopituitarism
Endocrine disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG00113 events12 affected101 at risk
EG0028 events8 affected74 at risk
EG003
Immune-mediated endocrinopathy
Endocrine disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Thyroiditis
Endocrine disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Cataract
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0012 events2 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Conjunctivitis allergic
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Dry eye
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Eyelid ptosis
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Eyelids pruritus
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Glaucoma
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Meibomian gland dysfunction
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Photopsia
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Retinal tear
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Vision blurred
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Visual impairment
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0003 events3 affected40 at risk
EG00110 events10 affected101 at risk
EG0028 events8 affected74 at risk
EG003
Abdominal hernia
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Abdominal mass
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0008 events7 affected40 at risk
EG00117 events15 affected101 at risk
EG00212 events10 affected74 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0003 events2 affected40 at risk
EG0015 events5 affected101 at risk
EG0023 events3 affected74 at risk
EG003
Anal incontinence
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Anorectal swelling
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0006 events6 affected40 at risk
EG0018 events8 affected101 at risk
EG00211 events10 affected74 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0007 events6 affected40 at risk
EG00114 events12 affected101 at risk
EG00210 events8 affected74 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG00017 events14 affected40 at risk
EG00120 events17 affected101 at risk
EG00220 events14 affected74 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0013 events2 affected101 at risk
EG0023 events3 affected74 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Anorectal discomfort
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Duodenal varices
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Dysbiosis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Dyschezia
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0012 events2 affected101 at risk
EG0026 events6 affected74 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Epigastric discomfort
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0022 events1 affected74 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0013 events3 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Frequent bowel movements
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Gastric varices
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Gastrointestinal inflammation
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Gastrointestinal pain
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Glossitis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Hyperaesthesia teeth
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0006 events6 affected40 at risk
EG00114 events12 affected101 at risk
EG00210 events10 affected74 at risk
EG003
Oesophageal varices haemorrhage
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Peptic ulcer
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Pigmentation lip
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Portal hypertensive gastropathy
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0013 events2 affected101 at risk
EG0022 events2 affected74 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0012 events2 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Varices oesophageal
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0006 events6 affected40 at risk
EG0015 events4 affected101 at risk
EG0027 events7 affected74 at risk
EG003
Adverse drug reaction
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Asthenia
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0013 events3 affected101 at risk
EG0023 events3 affected74 at risk
EG003
Catheter site pain
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Chest discomfort
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Chest pain
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Chills
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0022 events2 affected74 at risk
EG003
Face oedema
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Fatigue
General disorders
MedDRA 23.1
Systematic Assessment
EG00014 events13 affected40 at risk
EG00128 events23 affected101 at risk
EG00220 events17 affected74 at risk
EG003
Gait disturbance
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Generalised oedema
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Hyperthermia
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Influenza like illness
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0023 events3 affected74 at risk
EG003
Infusion site reaction
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Injection site erythema
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Localised oedema
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Malaise
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0012 events2 affected101 at risk
EG0023 events3 affected74 at risk
EG003
Mucosal hyperaemia
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Oedema
General disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Oedema peripheral
General disorders
MedDRA 23.1
Systematic Assessment
EG0004 events4 affected40 at risk
EG00115 events15 affected101 at risk
EG00214 events12 affected74 at risk
EG003
Pain
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Peripheral swelling
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Puncture site pain
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Pyrexia
General disorders
MedDRA 23.1
Systematic Assessment
EG0006 events5 affected40 at risk
EG0016 events4 affected101 at risk
EG00220 events11 affected74 at risk
EG003
Swelling
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Swelling face
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Thirst
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Ulcer
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Xerosis
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Bile duct stenosis
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Hepatic cirrhosis
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0025 events3 affected74 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Hepatomegaly
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Hepatorenal syndrome
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0014 events3 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0024 events3 affected74 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Portal vein thrombosis
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Anaphylactic shock
Immune system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Contrast media allergy
Immune system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Candida infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Cystitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Device related infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Ear infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Enterococcal bacteraemia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Escherichia infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Furuncle
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0012 events2 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Gastroenteritis salmonella
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Gastrointestinal candidiasis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Hepatitis b
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Influenza
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Liver abscess
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Myringitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0011 events1 affected101 at risk
EG0022 events2 affected74 at risk
EG003
Onychomycosis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Paronychia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Parotitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Peritonitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Peritonitis bacterial
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0013 events3 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Pyuria
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0012 events2 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Scrotal cellulitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Scrotal infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Sepsis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Skin bacterial infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0014 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0004 events4 affected40 at risk
EG0015 events4 affected101 at risk
EG0023 events3 affected74 at risk
EG003
Urethritis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0018 events7 affected101 at risk
EG0022 events2 affected74 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Viral infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Acquired pigmented retinopathy
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Allergic transfusion reaction
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0003 events3 affected40 at risk
EG0013 events2 affected101 at risk
EG0022 events2 affected74 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Post embolisation syndrome
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Radiation skin injury
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Skin wound
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Traumatic haematoma
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG00011 events9 affected40 at risk
EG00133 events23 affected101 at risk
EG00228 events17 affected74 at risk
EG003
Ammonia increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Amylase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0005 events4 affected40 at risk
EG0019 events8 affected101 at risk
EG00220 events12 affected74 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG00012 events9 affected40 at risk
EG00133 events26 affected101 at risk
EG00238 events23 affected74 at risk
EG003
Bilirubin conjugated increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Blood albumin decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0003 events3 affected40 at risk
EG00118 events11 affected101 at risk
EG0027 events7 affected74 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG00114 events10 affected101 at risk
EG00211 events7 affected74 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Blood creatine increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0013 events2 affected101 at risk
EG00212 events7 affected74 at risk
EG003
Blood glucose increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0013 events3 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Blood magnesium decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Blood potassium decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Blood pressure increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Blood pressure systolic increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Blood sodium decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Blood thyroid stimulating hormone decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0012 events2 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Blood uric acid increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0018 events6 affected101 at risk
EG0025 events5 affected74 at risk
EG003
Granulocyte count decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Heart rate decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Hepatitis b dna increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0014 events4 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Lipase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0009 events7 affected40 at risk
EG0017 events5 affected101 at risk
EG00220 events12 affected74 at risk
EG003
Liver function test increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0012 events2 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Low density lipoprotein increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0012 events2 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0002 events1 affected40 at risk
EG0016 events4 affected101 at risk
EG0022 events2 affected74 at risk
EG003
Platelet count decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0003 events2 affected40 at risk
EG00113 events6 affected101 at risk
EG0025 events2 affected74 at risk
EG003
Protein urine present
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Thyroid function test abnormal
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Thyroxine increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Transaminases increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Tri-iodothyronine increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Weight decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0005 events5 affected40 at risk
EG0014 events4 affected101 at risk
EG0024 events4 affected74 at risk
EG003
Weight increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0003 events2 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0022 events2 affected74 at risk
EG003
White blood cell count increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0007 events7 affected40 at risk
EG00115 events14 affected101 at risk
EG00211 events10 affected74 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0013 events2 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0012 events2 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Electrolyte imbalance
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Glucose tolerance impaired
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0012 events1 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Hyperalbuminaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0014 events4 affected101 at risk
EG0025 events2 affected74 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0012 events2 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG00111 events8 affected101 at risk
EG0028 events7 affected74 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0015 events5 affected101 at risk
EG0026 events2 affected74 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0012 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0004 events3 affected40 at risk
EG00110 events7 affected101 at risk
EG0023 events3 affected74 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0011 events1 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Hypochloraemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Hypoferritinaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0004 events2 affected40 at risk
EG0017 events6 affected101 at risk
EG0026 events5 affected74 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0019 events5 affected101 at risk
EG0024 events4 affected74 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0017 events5 affected101 at risk
EG0022 events2 affected74 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Hypoproteinaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0007 events7 affected40 at risk
EG0019 events8 affected101 at risk
EG0029 events8 affected74 at risk
EG003
Axillary mass
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0008 events7 affected40 at risk
EG00116 events15 affected101 at risk
EG0022 events2 affected74 at risk
EG003
Bone erosion
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Chondrocalcinosis pyrophosphate
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0013 events3 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Gouty arthritis
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Joint effusion
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Joint stiffness
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0012 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0012 events2 affected101 at risk
EG0022 events2 affected74 at risk
EG003
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0014 events4 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0012 events2 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0003 events3 affected40 at risk
EG0011 events1 affected101 at risk
EG0026 events4 affected74 at risk
EG003
Myofascial pain syndrome
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Myopathy
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0011 events1 affected101 at risk
EG0022 events2 affected74 at risk
EG003
Osteitis
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Osteonecrosis of jaw
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0004 events4 affected40 at risk
EG0012 events2 affected101 at risk
EG0024 events4 affected74 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Plantar fasciitis
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Psoriatic arthropathy
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Trigger finger
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0022 events2 affected74 at risk
EG003
Colon adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Fibrous histiocytoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Hypergammaglobulinaemia benign monoclonal
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Laryngeal papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Pituitary tumour benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Pyogenic granuloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0024 events2 affected74 at risk
EG003
Tumour invasion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0022 events2 affected74 at risk
EG003
Tumour thrombosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Amnesia
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Depressed level of consciousness
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0007 events4 affected40 at risk
EG0016 events6 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Dizziness postural
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0011 events1 affected101 at risk
EG0022 events2 affected74 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0015 events5 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Facial paralysis
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Headache
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0011 events1 affected101 at risk
EG0022 events2 affected74 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Hepatic encephalopathy
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0012 events2 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Hypokinesia
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Lacunar infarction
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Metabolic encephalopathy
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Monoparesis
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Myelopathy
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0022 events2 affected74 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Syncope
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Tremor
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0022 events1 affected74 at risk
EG003
Affect lability
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0012 events2 affected101 at risk
EG0022 events2 affected74 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0012 events2 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0012 events2 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Depression
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0012 events2 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0006 events6 affected40 at risk
EG0017 events7 affected101 at risk
EG0022 events2 affected74 at risk
EG003
Irritability
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Mood altered
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0013 events3 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Azotaemia
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0011 events1 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0012 events2 affected101 at risk
EG0022 events2 affected74 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Hypertonic bladder
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0012 events2 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Renal injury
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0011 events1 affected101 at risk
EG0024 events2 affected74 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Balanoposthitis
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Genital erythema
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Gynaecomastia
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0002 events1 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Nipple pain
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Oedema genital
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Penile pain
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Penile rash
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Sexual dysfunction
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Testicular pain
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Choking sensation
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0005 events5 affected40 at risk
EG00112 events12 affected101 at risk
EG00217 events15 affected74 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0011 events1 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0008 events8 affected40 at risk
EG00110 events10 affected101 at risk
EG0025 events4 affected74 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0003 events3 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Eosinophilic pneumonia
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0022 events2 affected74 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0011 events1 affected101 at risk
EG0022 events2 affected74 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0022 events2 affected74 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0003 events3 affected40 at risk
EG0012 events2 affected101 at risk
EG0022 events2 affected74 at risk
EG003
Paranasal sinus hypersecretion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0011 events1 affected101 at risk
EG0023 events3 affected74 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0003 events3 affected40 at risk
EG0012 events2 affected101 at risk
EG0023 events3 affected74 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Pulmonary thrombosis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Pulmonary toxicity
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Respiratory symptom
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0022 events1 affected74 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0022 events2 affected74 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0022 events2 affected74 at risk
EG003
Angioedema
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Dermatitis bullous
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0022 events1 affected74 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0022 events2 affected74 at risk
EG003
Dyshidrotic eczema
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0023 events3 affected74 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Erythema multiforme
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Erythema nodosum
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Intertrigo
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Lichen planus
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Lipodystrophy acquired
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Macule
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0003 events2 affected40 at risk
EG0010 events0 affected101 at risk
EG0022 events2 affected74 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Papule
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG00012 events11 affected40 at risk
EG00126 events20 affected101 at risk
EG00242 events29 affected74 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0022 events1 affected74 at risk
EG003
Purpura senile
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0005 events5 affected40 at risk
EG00113 events13 affected101 at risk
EG00233 events27 affected74 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0013 events3 affected101 at risk
EG0022 events2 affected74 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0011 events1 affected101 at risk
EG0022 events2 affected74 at risk
EG003
Skin hypopigmentation
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0012 events2 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0011 events1 affected101 at risk
EG0024 events3 affected74 at risk
EG003
Urticarial vasculitis
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Vitiligo
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0012 events2 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Bloody discharge
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Embolism
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0012 events2 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Flushing
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Haematoma
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Hyperaemia
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Hypertension
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0016 events4 affected101 at risk
EG0025 events4 affected74 at risk
EG003
Hypotension
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0014 events4 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Inferior vena caval occlusion
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Intermittent claudication
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Systolic hypertension
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected101 at risk
EG0020 events0 affected74 at risk
EG003
Vena cava thrombosis
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Venous thrombosis limb
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected101 at risk
EG0021 events1 affected74 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Participants received durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG002
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg
Participants received tremelimumab 300 mg 1 dose and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow, or development of other reason for treatment discontinuation, whichever occurred first.
OG003
Parts 2 and 3: Tremelimumab 750 mg
Participants received tremelimumab 750 mg Q4W 7 doses followed by every 12 weeks (Q12W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG004
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg
Participants received tremelimumab 75 mg Q4W 4 doses and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG005
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg
Participants received durvalumab 1120 mg and bevacizumab 15 mg/kg every 3 weeks (Q3W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG006
China Cohort: Durvalumab 20 mg/kg
Participants received durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG007
China Cohort: Tremelimumab 10 mg/kg
Participants received tremelimumab 10 mg/kg Q4W 7 doses followed by Q12W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG008
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg
Participants received tremelimumab 1 mg/kg Q4W 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Units
Counts
Participants
OG00040
OG001101
OG00274
OG00369
OG00482
OG00547
OG0063
OG0075
OG0085
Title
Denominators
Categories
Any TEAEs
Title
Measurements
OG00038
OG00195
OG00273
OG00367
OG00480
OG00545
OG0063
OG0075
OG0085
Any TESAEs
Title
Measurements
OG00022
OG00145
OG00232
OG003
OG002
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg
Participants received tremelimumab 300 mg 1 dose and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow, or development of other reason for treatment discontinuation, whichever occurred first.
OG003
Parts 2 and 3: Tremelimumab 750 mg
Participants received tremelimumab 750 mg Q4W 7 doses followed by every 12 weeks (Q12W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG004
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg
Participants received tremelimumab 75 mg Q4W 4 doses and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG005
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg
Participants received durvalumab 1120 mg and bevacizumab 15 mg/kg every 3 weeks (Q3W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG006
China Cohort: Durvalumab 20 mg/kg
Participants received durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG007
China Cohort: Tremelimumab 10 mg/kg
Participants received tremelimumab 10 mg/kg Q4W 7 doses followed by Q12W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG008
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg
Participants received tremelimumab 1 mg/kg Q4W 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Units
Counts
Participants
OG00039
OG001100
OG00274
OG00368
OG00481
OG00546
OG0063
OG0075
OG0084
Title
Denominators
Categories
Hemoglobin
ParticipantsOG00038
ParticipantsOG00199
ParticipantsOG00271
ParticipantsOG00367
ParticipantsOG00479
ParticipantsOG00544
ParticipantsOG0063
ParticipantsOG0074
ParticipantsOG0083
Title
Measurements
OG0000
OG0015
OG0026
OG003
Leukocytes
ParticipantsOG00038
ParticipantsOG00199
ParticipantsOG00271
ParticipantsOG00367
Lymphocytes
ParticipantsOG00029
ParticipantsOG00175
ParticipantsOG00252
ParticipantsOG00355
Neutrophils
ParticipantsOG00033
ParticipantsOG00175
ParticipantsOG00251
ParticipantsOG00355
Platelets
ParticipantsOG00037
ParticipantsOG00199
ParticipantsOG00271
ParticipantsOG00367
Activated Partial Thromboplastin Time
ParticipantsOG00034
ParticipantsOG00198
ParticipantsOG00269
ParticipantsOG00368
Fibrinogen
ParticipantsOG00034
ParticipantsOG00195
ParticipantsOG00266
ParticipantsOG00364
Prothrombin Intl. Normalized Ratio
ParticipantsOG00039
ParticipantsOG001100
ParticipantsOG00274
ParticipantsOG00367
Alanine Aminotransferase
ParticipantsOG00038
ParticipantsOG00199
ParticipantsOG00271
ParticipantsOG00367
Albumin
ParticipantsOG00038
ParticipantsOG00199
ParticipantsOG00271
ParticipantsOG00367
Alkaline Phosphatase
ParticipantsOG00038
ParticipantsOG00199
ParticipantsOG00271
ParticipantsOG00367
Aspartate Aminotransferase
ParticipantsOG00038
ParticipantsOG00199
ParticipantsOG00271
ParticipantsOG00367
Bilirubin
ParticipantsOG00038
ParticipantsOG00199
ParticipantsOG00271
ParticipantsOG00367
Calcium - Hyper
ParticipantsOG00037
ParticipantsOG00199
ParticipantsOG00271
ParticipantsOG00367
Calcium - Hypo
ParticipantsOG00037
ParticipantsOG00199
ParticipantsOG00271
ParticipantsOG00367
Creatinine
ParticipantsOG00038
ParticipantsOG00199
ParticipantsOG00271
ParticipantsOG00367
Glucose - Hyper
ParticipantsOG00038
ParticipantsOG00199
ParticipantsOG00271
ParticipantsOG00367
Glucose - Hypo
ParticipantsOG00038
ParticipantsOG00199
ParticipantsOG00271
ParticipantsOG00367
Magnesium - Hyper
ParticipantsOG00037
ParticipantsOG00198
ParticipantsOG00270
ParticipantsOG00367
Magnesium - Hypo
ParticipantsOG00037
ParticipantsOG00198
ParticipantsOG00270
ParticipantsOG00367
Potassium - Hyper
ParticipantsOG00038
ParticipantsOG00198
ParticipantsOG00271
ParticipantsOG00367
Potassium - Hypo
ParticipantsOG00038
ParticipantsOG00198
ParticipantsOG00271
ParticipantsOG00367
Sodium - Hyper
ParticipantsOG00038
ParticipantsOG00199
ParticipantsOG00271
ParticipantsOG00367
Sodium - Hypo
ParticipantsOG00038
ParticipantsOG00199
ParticipantsOG00271
ParticipantsOG00367
Participants received tremelimumab 300 mg 1 dose and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow, or development of other reason for treatment discontinuation, whichever occurred first.
OG003
Parts 2 and 3: Tremelimumab 750 mg
Participants received tremelimumab 750 mg Q4W 7 doses followed by every 12 weeks (Q12W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG004
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg
Participants received tremelimumab 75 mg Q4W 4 doses and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG005
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg
Participants received durvalumab 1120 mg and bevacizumab 15 mg/kg every 3 weeks (Q3W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG006
China Cohort: Durvalumab 20 mg/kg
Participants received durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG007
China Cohort: Tremelimumab 10 mg/kg
Participants received tremelimumab 10 mg/kg Q4W 7 doses followed by Q12W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG008
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg
Participants received tremelimumab 1 mg/kg Q4W 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Units
Counts
Participants
OG00040
OG001101
OG00274
OG00369
OG00482
OG00547
OG0063
OG0075
OG0085
Title
Denominators
Categories
Hypertension
Title
Measurements
OG0001
OG0014
OG0024
OG0032
OG0043
OG0056
OG0060
OG0070
OG0080
Hypotension
Title
Measurements
OG0000
OG0014
OG0020
OG003
Systolic hypertension
Title
Measurements
OG0000
OG0011
OG0020
OG003
Weight decreased
Title
Measurements
OG0004
OG0014
OG0024
OG003
Weight increased
Title
Measurements
OG0002
OG0010
OG0021
OG003
Palpitations
Title
Measurements
OG0001
OG0010
OG0020
OG003
Pyrexia
Title
Measurements
OG0006
OG0016
OG00214
OG003
Participants received tremelimumab 300 mg 1 dose and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow, or development of other reason for treatment discontinuation, whichever occurred first.
OG003
Parts 2 and 3: Tremelimumab 750 mg
Participants received tremelimumab 750 mg Q4W 7 doses followed by every 12 weeks (Q12W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG004
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg
Participants received tremelimumab 75 mg Q4W 4 doses and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG005
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg
Participants received durvalumab 1120 mg and bevacizumab 15 mg/kg every 3 weeks (Q3W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG006
China Cohort: Durvalumab 20 mg/kg
Participants received durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG007
China Cohort: Tremelimumab 10 mg/kg
Participants received tremelimumab 10 mg/kg Q4W 7 doses followed by Q12W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG008
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg
Participants received tremelimumab 1 mg/kg Q4W 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Units
Counts
Participants
OG00040
OG001101
OG00274
OG00369
OG00482
OG00547
OG0063
OG0075
OG0085
Title
Denominators
Categories
Acute myocardial infarction
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
Angina pectoris
Title
Measurements
OG0000
OG0010
OG0020
OG003
Angina unstable
Title
Measurements
OG0000
OG0010
OG0020
OG003
Atrial fibrillation
Title
Measurements
OG0001
OG0011
OG0021
OG003
Cardiac failure chronic
Title
Measurements
OG0000
OG0010
OG0021
OG003
Cardiac failure congestive
Title
Measurements
OG0000
OG0011
OG0021
OG003
Coronary artery disease
Title
Measurements
OG0000
OG0011
OG0020
OG003
Sinus bradycardia
Title
Measurements
OG0000
OG0011
OG0020
OG003
Tachycardia
Title
Measurements
OG0000
OG0010
OG0021
OG003
Atrioventricular block first degree
Title
Measurements
OG0001
OG0010
OG0020
OG003
Cardiac arrest
Title
Measurements
OG0001
OG0010
OG0020
OG003
Myocardial infarction
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG001
Parts 2 and 3: Durvalumab 1500 mg
Participants received durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG002
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg
Participants received tremelimumab 300 mg 1 dose and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow, or development of other reason for treatment discontinuation, whichever occurred first.
OG003
Parts 2 and 3: Tremelimumab 750 mg
Participants received tremelimumab 750 mg Q4W 7 doses followed by every 12 weeks (Q12W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG004
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg
Participants received tremelimumab 75 mg Q4W 4 doses and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG005
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg
Participants received durvalumab 1120 mg and bevacizumab 15 mg/kg every 3 weeks (Q3W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG006
China Cohort: Durvalumab 20 mg/kg
Participants received durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG007
China Cohort: Tremelimumab 10 mg/kg
Participants received tremelimumab 10 mg/kg Q4W 7 doses followed by Q12W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG008
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg
Participants received tremelimumab 1 mg/kg Q4W 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Units
Counts
Participants
OG00040
OG001104
OG00275
OG00369
OG00484
OG00547
OG0063
OG0075
OG0086
Title
Denominators
Categories
ORR based on BICR
ParticipantsOG0000
ParticipantsOG001104
ParticipantsOG00275
ParticipantsOG00369
ParticipantsOG00484
ParticipantsOG00547
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG00111.5(6.1 to 19.3)
OG00224.0(14.9 to 35.3)
OG0037.2(2.4 to 16.1)
OG004
ORR based on Investigator assessments
ParticipantsOG00040
ParticipantsOG001104
ParticipantsOG00275
ParticipantsOG00369
OG001
Parts 2 and 3: Durvalumab 1500 mg
Participants received durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG002
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg
Participants received tremelimumab 300 mg 1 dose and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow, or development of other reason for treatment discontinuation, whichever occurred first.
OG003
Parts 2 and 3: Tremelimumab 750 mg
Participants received tremelimumab 750 mg Q4W 7 doses followed by every 12 weeks (Q12W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG004
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg
Participants received tremelimumab 75 mg Q4W 4 doses and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG005
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg
Participants received durvalumab 1120 mg and bevacizumab 15 mg/kg every 3 weeks (Q3W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG006
China Cohort: Durvalumab 20 mg/kg
Participants received durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG007
China Cohort: Tremelimumab 10 mg/kg
Participants received tremelimumab 10 mg/kg Q4W 7 doses followed by Q12W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG008
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg
Participants received tremelimumab 1 mg/kg Q4W 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Units
Counts
Participants
OG00040
OG001104
OG00275
OG00369
OG00484
OG00547
OG0063
OG0075
OG0086
Title
Denominators
Categories
DCR based on BICR
ParticipantsOG0000
ParticipantsOG001104
ParticipantsOG00275
ParticipantsOG00369
ParticipantsOG00484
ParticipantsOG00547
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG00137.5
OG00245.3
OG00349.3
OG004
DCR based on Investigator assessments
ParticipantsOG00040
ParticipantsOG001104
ParticipantsOG00275
ParticipantsOG00369
OG001
Parts 2 and 3: Durvalumab 1500 mg
Participants received durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG002
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg
Participants received tremelimumab 300 mg 1 dose and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow, or development of other reason for treatment discontinuation, whichever occurred first.
OG003
Parts 2 and 3: Tremelimumab 750 mg
Participants received tremelimumab 750 mg Q4W 7 doses followed by every 12 weeks (Q12W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG004
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg
Participants received tremelimumab 75 mg Q4W 4 doses and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG005
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg
Participants received durvalumab 1120 mg and bevacizumab 15 mg/kg every 3 weeks (Q3W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG006
China Cohort: Durvalumab 20 mg/kg
Participants received durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG007
China Cohort: Tremelimumab 10 mg/kg
Participants received tremelimumab 10 mg/kg Q4W 7 doses followed by Q12W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG008
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg
Participants received tremelimumab 1 mg/kg Q4W 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Units
Counts
Participants
OG0008
OG00112
OG00218
OG0036
OG0048
OG00516
OG0061
OG0070
OG0080
Title
Denominators
Categories
TTR based on BICR
ParticipantsOG0000
ParticipantsOG00112
ParticipantsOG00218
ParticipantsOG0035
ParticipantsOG0048
ParticipantsOG00510
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG0013.65(2.71 to 5.59)
OG0022.28(1.81 to 3.68)
OG0031.81(1.81 to 1.84)
OG004
TTR based on Investigator assessments
ParticipantsOG0008
ParticipantsOG00112
ParticipantsOG00216
ParticipantsOG0036
OG001
Parts 2 and 3: Durvalumab 1500 mg
Participants received durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG002
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg
Participants received tremelimumab 300 mg 1 dose and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow, or development of other reason for treatment discontinuation, whichever occurred first.
OG003
Parts 2 and 3: Tremelimumab 750 mg
Participants received tremelimumab 750 mg Q4W 7 doses followed by every 12 weeks (Q12W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG004
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg
Participants received tremelimumab 75 mg Q4W 4 doses and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG005
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg
Participants received durvalumab 1120 mg and bevacizumab 15 mg/kg every 3 weeks (Q3W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG006
China Cohort: Durvalumab 20 mg/kg
Participants received durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG007
China Cohort: Tremelimumab 10 mg/kg
Participants received tremelimumab 10 mg/kg Q4W 7 doses followed by Q12W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG008
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg
Participants received tremelimumab 1 mg/kg Q4W 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Units
Counts
Participants
OG0008
OG00112
OG00218
OG0036
OG0048
OG00516
OG0061
OG0070
OG0080
Title
Denominators
Categories
DoR based on BICR
ParticipantsOG0000
ParticipantsOG00112
ParticipantsOG00218
ParticipantsOG0035
ParticipantsOG0048
ParticipantsOG00510
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG00114.95(8.54 to NA)75th percentile could not be derived due to insufficient events being observed at the time of the analysis.
OG00218.43(5.59 to 23.95)
OG00323.95(4.07 to NA)75th percentile could not be derived due to insufficient events being observed at the time of the analysis.
OG004
DoR based on Investigator assessments
ParticipantsOG0008
ParticipantsOG00112
ParticipantsOG00216
ParticipantsOG0036
OG001
Parts 2 and 3: Durvalumab 1500 mg
Participants received durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG002
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg
Participants received tremelimumab 300 mg 1 dose and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow, or development of other reason for treatment discontinuation, whichever occurred first.
OG003
Parts 2 and 3: Tremelimumab 750 mg
Participants received tremelimumab 750 mg Q4W 7 doses followed by every 12 weeks (Q12W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG004
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg
Participants received tremelimumab 75 mg Q4W 4 doses and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG005
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg
Participants received durvalumab 1120 mg and bevacizumab 15 mg/kg every 3 weeks (Q3W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG006
China Cohort: Durvalumab 20 mg/kg
Participants received durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG007
China Cohort: Tremelimumab 10 mg/kg
Participants received tremelimumab 10 mg/kg Q4W 7 doses followed by Q12W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG008
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg
Participants received tremelimumab 1 mg/kg Q4W 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Units
Counts
Participants
OG00040
OG001104
OG00275
OG00369
OG00484
OG00547
OG0063
OG0075
OG0086
Title
Denominators
Categories
TTP based on BICR
ParticipantsOG0000
ParticipantsOG001104
ParticipantsOG00275
ParticipantsOG00369
ParticipantsOG00484
ParticipantsOG00547
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG0012.10(1.87 to 3.52)
OG0023.71(1.91 to 5.55)
OG0032.76(1.87 to 5.42)
OG004
TTP based on Investigator assessments
ParticipantsOG00040
ParticipantsOG001104
ParticipantsOG00275
ParticipantsOG00369
OG001
Parts 2 and 3: Durvalumab 1500 mg
Participants received durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG002
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg
Participants received tremelimumab 300 mg 1 dose and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow, or development of other reason for treatment discontinuation, whichever occurred first.
OG003
Parts 2 and 3: Tremelimumab 750 mg
Participants received tremelimumab 750 mg Q4W 7 doses followed by every 12 weeks (Q12W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG004
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg
Participants received tremelimumab 75 mg Q4W 4 doses and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG005
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg
Participants received durvalumab 1120 mg and bevacizumab 15 mg/kg every 3 weeks (Q3W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG006
China Cohort: Durvalumab 20 mg/kg
Participants received durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG007
China Cohort: Tremelimumab 10 mg/kg
Participants received tremelimumab 10 mg/kg Q4W 7 doses followed by Q12W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG008
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg
Participants received tremelimumab 1 mg/kg Q4W 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Units
Counts
Participants
OG00040
OG001104
OG00275
OG00369
OG00484
OG00547
OG0063
OG0075
OG0086
Title
Denominators
Categories
PFS based on BICR
ParticipantsOG0000
ParticipantsOG001104
ParticipantsOG00275
ParticipantsOG00369
ParticipantsOG00484
ParticipantsOG00547
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG0012.07(1.84 to 2.86)
OG0022.17(1.91 to 5.42)
OG0032.69(1.87 to 5.29)
OG004
PFS based on Investigator assessments
ParticipantsOG00040
ParticipantsOG001104
ParticipantsOG00275
ParticipantsOG00369
OG002
Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg
Participants received tremelimumab 300 mg 1 dose and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow, or development of other reason for treatment discontinuation, whichever occurred first.
OG003
Parts 2 and 3: Tremelimumab 750 mg
Participants received tremelimumab 750 mg Q4W 7 doses followed by every 12 weeks (Q12W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG004
Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg
Participants received tremelimumab 75 mg Q4W 4 doses and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG005
Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg
Participants received durvalumab 1120 mg and bevacizumab 15 mg/kg every 3 weeks (Q3W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG006
China Cohort: Durvalumab 20 mg/kg
Participants received durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG007
China Cohort: Tremelimumab 10 mg/kg
Participants received tremelimumab 10 mg/kg Q4W 7 doses followed by Q12W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
OG008
China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg
Participants received tremelimumab 1 mg/kg Q4W 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Units
Counts
Participants
OG00040
OG001104
OG00275
OG00369
OG00484
OG00547
OG0063
OG0075
OG0086
Title
Denominators
Categories
Title
Measurements
OG00012.58(6.87 to 20.99)
OG00112.91(8.74 to 16.79)
OG00217.05(10.55 to 22.83)
OG00317.05(11.33 to 20.24)
OG00411.30(8.38 to 14.95)
OG005NA(12.52 to NA)Median and upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.
OG00630.69(13.96 to NA)Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.
OG0073.52(2.20 to 20.96)
OG0086.28(0.66 to 23.82)
2 events
2 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0051 events1 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
2 events
1 affected
69 at risk
EG0042 events2 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
1 events
1 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
1 events
1 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
1 events
1 affected
69 at risk
EG0040 events0 affected82 at risk
EG0051 events1 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
1 events
1 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0042 events1 affected82 at risk
EG0051 events1 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0051 events1 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0041 events1 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
1 events
1 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0041 events1 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0042 events1 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
1 events
1 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0049 events2 affected82 at risk
EG0052 events2 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0083 events2 affected5 at risk
0 events
0 affected
69 at risk
EG0041 events1 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0042 events2 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
1 events
1 affected
69 at risk
EG0041 events1 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
6 events
6 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
1 events
1 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0051 events1 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
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0 events
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12 events
9 affected
69 at risk
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1 events
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2 events
2 affected
69 at risk
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2 events
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69 at risk
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0 events
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0 events
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1 events
1 affected
69 at risk
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2 events
2 affected
69 at risk
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0 events
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0 events
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0 events
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1 events
1 affected
69 at risk
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0 events
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0 events
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1 events
1 affected
69 at risk
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0 events
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1 events
1 affected
69 at risk
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0 events
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0 events
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1 events
1 affected
69 at risk
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1 events
1 affected
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1 events
1 affected
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1 events
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9 events
8 affected
69 at risk
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11 affected
69 at risk
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8 affected
69 at risk
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69 at risk
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69 at risk
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16 events
10 affected
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1 affected
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1 events
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11 events
6 affected
69 at risk
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2 events
1 affected
69 at risk
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30 events
14 affected
69 at risk
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1 events
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7 events
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5 events
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16 affected
69 at risk
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3 events
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69 at risk
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69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0041 events1 affected82 at risk
EG0050 events0 affected47 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG00517 events11 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0041 events1 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0041 events1 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0051 events1 affected47 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0051 events1 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0051 events1 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
1 events
1 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0041 events1 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0041 events1 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0051 events1 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
17 events
11 affected
69 at risk
EG00418 events15 affected82 at risk
EG0054 events4 affected47 at risk
EG0060 events0 affected3 at risk
EG0072 events2 affected5 at risk
EG0080 events0 affected5 at risk
1 events
1 affected
69 at risk
EG0042 events2 affected82 at risk
EG0054 events4 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
5 events
5 affected
69 at risk
EG0049 events6 affected82 at risk
EG0051 events1 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0041 events1 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0041 events1 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
1 events
1 affected
69 at risk
EG0040 events0 affected82 at risk
EG0056 events6 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
2 events
1 affected
69 at risk
EG0043 events3 affected82 at risk
EG0051 events1 affected47 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected5 at risk
2 events
2 affected
69 at risk
EG0041 events1 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0041 events1 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
6 events
6 affected
69 at risk
EG0042 events2 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0041 events1 affected82 at risk
EG0051 events1 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
1 events
1 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
1 events
1 affected
69 at risk
EG0042 events2 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
1 events
1 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
2 events
2 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0041 events1 affected82 at risk
EG0051 events1 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0051 events1 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
1 events
1 affected
69 at risk
EG0041 events1 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
1 events
1 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0043 events1 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
1 events
1 affected
69 at risk
EG0042 events2 affected82 at risk
EG0051 events1 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0041 events1 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
1 events
1 affected
69 at risk
EG0040 events0 affected82 at risk
EG0052 events2 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0041 events1 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0041 events1 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
5 events
5 affected
69 at risk
EG0042 events2 affected82 at risk
EG0053 events3 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
1 events
1 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
2 events
2 affected
69 at risk
EG0042 events2 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
1 events
1 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
1 events
1 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
1 events
1 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
1 events
1 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
1 events
1 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0041 events1 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0051 events1 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
1 events
1 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
38 events
28 affected
69 at risk
EG00425 events21 affected82 at risk
EG0056 events4 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0041 events1 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
27 events
20 affected
69 at risk
EG00415 events14 affected82 at risk
EG0055 events5 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
2 events
2 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
10 events
8 affected
69 at risk
EG0047 events6 affected82 at risk
EG0051 events1 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
2 events
2 affected
69 at risk
EG0041 events1 affected82 at risk
EG0051 events1 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0042 events2 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0041 events1 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
4 events
4 affected
69 at risk
EG0041 events1 affected82 at risk
EG0051 events1 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0041 events1 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0041 events1 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
1 events
1 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0051 events1 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
2 events
2 affected
69 at risk
EG0049 events3 affected82 at risk
EG0056 events6 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
2 events
2 affected
69 at risk
EG0042 events2 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
69 at risk
EG0040 events0 affected82 at risk
EG0050 events0 affected47 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
36
OG00437
OG00517
OG0061
OG0073
OG0084
6
OG0046
OG0050
OG0060
OG0071
OG0081
Participants
OG004
79
ParticipantsOG00544
ParticipantsOG0063
ParticipantsOG0074
ParticipantsOG0083
Title
Measurements
OG0001
OG0011
OG0021
OG0031
OG0042
OG0051
OG0060
OG0070
OG0080
Participants
OG004
65
ParticipantsOG00524
ParticipantsOG0063
ParticipantsOG0074
ParticipantsOG0083
Title
Measurements
OG0003
OG0017
OG00210
OG0034
OG0048
OG0052
OG0060
OG0071
OG0080
Participants
OG004
65
ParticipantsOG00532
ParticipantsOG0063
ParticipantsOG0074
ParticipantsOG0083
Title
Measurements
OG0000
OG0011
OG0021
OG0030
OG0040
OG0051
OG0060
OG0070
OG0080
Participants
OG004
79
ParticipantsOG00544
ParticipantsOG0063
ParticipantsOG0074
ParticipantsOG0083
Title
Measurements
OG0003
OG0015
OG0020
OG0032
OG0044
OG0053
OG0061
OG0070
OG0080
ParticipantsOG00478
ParticipantsOG00544
ParticipantsOG0063
ParticipantsOG0074
ParticipantsOG0083
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0051
OG0060
OG0070
OG0080
Participants
OG004
76
ParticipantsOG00544
ParticipantsOG0063
ParticipantsOG0074
ParticipantsOG0083
Title
Measurements
OG0005
OG0015
OG0025
OG0032
OG0045
OG0053
OG0060
OG0070
OG0080
ParticipantsOG00481
ParticipantsOG00546
ParticipantsOG0063
ParticipantsOG0075
ParticipantsOG0084
Title
Measurements
OG0000
OG0011
OG0023
OG0031
OG0040
OG0051
OG0060
OG0070
OG0080
ParticipantsOG00478
ParticipantsOG00545
ParticipantsOG0063
ParticipantsOG0074
ParticipantsOG0083
Title
Measurements
OG0003
OG0017
OG00213
OG0035
OG00410
OG0051
OG0060
OG0070
OG0080
Participants
OG004
78
ParticipantsOG00545
ParticipantsOG0063
ParticipantsOG0074
ParticipantsOG0083
Title
Measurements
OG0001
OG0015
OG0020
OG0033
OG0043
OG0050
OG0060
OG0070
OG0080
ParticipantsOG00478
ParticipantsOG00545
ParticipantsOG0063
ParticipantsOG0074
ParticipantsOG0083
Title
Measurements
OG0003
OG00113
OG0024
OG0036
OG0048
OG0053
OG0061
OG0070
OG0081
ParticipantsOG00478
ParticipantsOG00545
ParticipantsOG0063
ParticipantsOG0074
ParticipantsOG0083
Title
Measurements
OG0005
OG00125
OG00219
OG00316
OG00417
OG0054
OG0060
OG0071
OG0081
Participants
OG004
78
ParticipantsOG00545
ParticipantsOG0063
ParticipantsOG0074
ParticipantsOG0083
Title
Measurements
OG0002
OG00112
OG0024
OG0036
OG0049
OG0052
OG0060
OG0070
OG0080
ParticipantsOG00478
ParticipantsOG00545
ParticipantsOG0063
ParticipantsOG0074
ParticipantsOG0083
Title
Measurements
OG0000
OG0014
OG0020
OG0031
OG0043
OG0051
OG0060
OG0070
OG0080
ParticipantsOG00478
ParticipantsOG00545
ParticipantsOG0063
ParticipantsOG0074
ParticipantsOG0083
Title
Measurements
OG0001
OG0012
OG0021
OG0031
OG0041
OG0050
OG0060
OG0070
OG0080
Participants
OG004
78
ParticipantsOG00545
ParticipantsOG0063
ParticipantsOG0074
ParticipantsOG0083
Title
Measurements
OG0002
OG0012
OG0023
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
ParticipantsOG00478
ParticipantsOG00545
ParticipantsOG0063
ParticipantsOG0074
ParticipantsOG0083
Title
Measurements
OG0004
OG0018
OG00214
OG0036
OG0045
OG0052
OG0060
OG0070
OG0080
ParticipantsOG00478
ParticipantsOG00545
ParticipantsOG0063
ParticipantsOG0074
ParticipantsOG0083
Title
Measurements
OG0002
OG0011
OG0020
OG0031
OG0040
OG0051
OG0060
OG0070
OG0080
ParticipantsOG00478
ParticipantsOG00545
ParticipantsOG0063
ParticipantsOG0074
ParticipantsOG0083
Title
Measurements
OG0002
OG0017
OG0023
OG0032
OG0042
OG0052
OG0060
OG0070
OG0080
ParticipantsOG00478
ParticipantsOG00545
ParticipantsOG0063
ParticipantsOG0074
ParticipantsOG0083
Title
Measurements
OG0000
OG0012
OG0020
OG0031
OG0040
OG0051
OG0060
OG0070
OG0080
ParticipantsOG00478
ParticipantsOG00545
ParticipantsOG0063
ParticipantsOG0074
ParticipantsOG0083
Title
Measurements
OG0004
OG0014
OG0022
OG0030
OG0043
OG0051
OG0060
OG0070
OG0080
ParticipantsOG00478
ParticipantsOG00545
ParticipantsOG0063
ParticipantsOG0074
ParticipantsOG0083
Title
Measurements
OG0000
OG0012
OG0022
OG0032
OG0041
OG0050
OG0060
OG0070
OG0080
ParticipantsOG00478
ParticipantsOG00545
ParticipantsOG0063
ParticipantsOG0074
ParticipantsOG0083
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
ParticipantsOG00478
ParticipantsOG00545
ParticipantsOG0063
ParticipantsOG0074
ParticipantsOG0083
Title
Measurements
OG0009
OG00112
OG0027
OG00313
OG00411
OG0056
OG0060
OG0070
OG0081
3
OG0042
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
4
OG0044
OG0052
OG0060
OG0070
OG0081
1
OG0042
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0061
OG0070
OG0080
9
OG00414
OG0054
OG0062
OG0072
OG0081
1
OG0041
OG0052
OG0060
OG0070
OG0080
1
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0043
OG0051
OG0061
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0041
OG0050
OG0060
OG0070
OG0080
0
OG0041
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0051
OG0060
OG0070
OG0080
9.5
(4.2 to 17.9)
OG00521.3(10.7 to 35.7)
ParticipantsOG00484
ParticipantsOG00547
ParticipantsOG0063
ParticipantsOG0075
ParticipantsOG0086
Title
Measurements
OG00020.0(9.1 to 35.6)
OG00111.5(6.1 to 19.3)
OG00221.3(12.7 to 32.3)
OG0038.7(3.3 to 18.0)
OG0048.3(3.4 to 16.4)
OG00534.0(20.9 to 49.3)
OG00633.3(0.8 to 90.6)
OG007NA(NA to NA)No participants reported a best overall response of CR or PR.
OG008NA(NA to NA)No participants reported a best overall response of CR or PR.
36.9
OG00555.3
ParticipantsOG00484
ParticipantsOG00547
ParticipantsOG0063
ParticipantsOG0075
ParticipantsOG0086
Title
Measurements
OG00060.0
OG00145.2
OG00250.7
OG00347.8
OG00434.5
OG00563.8
OG00633.3
OG00720.0
OG00816.7
2.86
(1.84 to 3.83)
OG0052.10(1.87 to 4.11)
ParticipantsOG0047
ParticipantsOG00516
ParticipantsOG0061
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG0002.68(1.82 to 4.60)
OG0013.68(1.81 to 5.55)
OG0021.86(1.77 to 5.59)
OG0032.74(1.81 to 5.32)
OG0043.88(1.81 to 5.32)
OG0052.10(1.94 to 4.12)
OG0065.55(5.55 to 5.55)
13.21
(10.15 to NA)
75th percentile could not be derived due to insufficient events being observed at the time of the analysis.
OG005NA(6.28 to NA)Median and 75th percentile could not be derived due to insufficient events being observed at the time of the analysis.
ParticipantsOG0047
ParticipantsOG00516
ParticipantsOG0061
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG00016.66(8.41 to NA)75th percentile could not be derived due to insufficient events being observed at the time of the analysis.
OG001NA(19.02 to NA)Median and 75th percentile could not be derived due to insufficient events being observed at the time of the analysis.
OG00223.95(5.59 to NA)75th percentile could not be derived due to insufficient events being observed at the time of the analysis.
OG00327.53(27.53 to NA)75th percentile could not be derived due to insufficient events being observed at the time of the analysis.
OG00413.21(12.85 to NA)75th percentile could not be derived due to insufficient events being observed at the time of the analysis.
OG00510.51(10.51 to NA)75th percentile could not be derived due to insufficient events being observed at the time of the analysis.
OG0067.39(7.39 to 7.39)
1.87
(1.81 to 3.48)
OG0054.30(2.10 to 6.24)
ParticipantsOG00484
ParticipantsOG00547
ParticipantsOG0063
ParticipantsOG0075
ParticipantsOG0086
Title
Measurements
OG0003.68(2.23 to 6.77)
OG0013.38(2.00 to 4.67)
OG0023.68(2.07 to 5.52)
OG0032.60(1.87 to 5.29)
OG0041.87(1.77 to 3.48)
OG0057.46(4.01 to NA)Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.