An Investigational Immuno-therapy Study to Test Combinati... | NCT02750514 | Trialant
NCT02750514
Sponsor
Bristol-Myers Squibb
Status
Terminated
Last Update Posted
Mar 22, 2021Actual
Enrollment
295Actual
Phase
Phase 2
Conditions
Advanced Cancer
Interventions
Nivolumab
Dasatinib
Relatlimab
Ipilimumab
BMS-986205
Countries
United States
Australia
Austria
Canada
France
Italy
Spain
Switzerland
Protocol Section
Identification Module
NCT ID
NCT02750514
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CA018-001
Secondary IDs
Not provided
Brief Title
An Investigational Immuno-therapy Study to Test Combination Treatments in Patients With Advanced Non-Small Cell Lung Cancer
Official Title
A Phase 2, Fast Real Time Assessment of Combination Therapies in Immuno-Oncology Study in Subjects With Advanced Non-Small Cell Lung Cancer (FRACTION-Lung)
Acronym
FRACTION-Lung
Organization
Bristol-Myers SquibbINDUSTRY
Status Module
Record Verification Date
Feb 2021
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The standard of care for the patient population changed and we were unable to accrue any longer.
Expanded Access Info
No
Start Date
May 9, 2016Actual
Primary Completion Date
Jan 29, 2020Actual
Completion Date
Jan 29, 2020Actual
First Submitted Date
Apr 21, 2016
First Submission Date that Met QC Criteria
Apr 22, 2016
First Posted Date
Apr 25, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 27, 2021
Results First Submitted that Met QC Criteria
Feb 23, 2021
Results First Posted Date
Mar 22, 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
Feb 23, 2021
Last Update Posted Date
Mar 22, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Bristol-Myers SquibbINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
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
The purpose of this study is to determine whether Nivolumab, in combination with other therapies, is effective in patients with advanced Non-Small Cell lung cancer
Detailed Description
Not provided
Conditions Module
Conditions
Advanced Cancer
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
295Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Nivolumab
Active Comparator
Nivolumab Monotherapy - Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator
Biological: Nivolumab
Nivolumab & Dasatinib
Experimental
Nivolumab in combination with Dasatinib
Biological: Nivolumab
Drug: Dasatinib
Nivolumab & Relatlimab
Experimental
Nivolumab in combination with Relatlimab
Biological: Nivolumab
Biological: Relatlimab
Nivolumab & Ipilimumab
Experimental
Nivolumab in combination with Ipilimumab
Biological: Nivolumab
Biological: Ipilimumab
Nivolumab & BMS-986205
Experimental
Nivolumab in combination with BMS- 986205
Biological: Nivolumab
Drug: BMS-986205
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Nivolumab
Biological
Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator.
Nivolumab
Nivolumab & BMS-986205
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Objective Response Rate (ORR)
ORR is defined as the percentage of participants whose confirmed best overall response (BOR) is either a complete response (CR) or partial response (PR). BOR was assessed by investigator per RECIST1.1.
Results are presented by study track. Track 1 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = participants with prior anti-PD-1/PD-L1 therapy Track 4 = participants naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = participants with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
Results for each study track are presented only for treatment groups who received a treatment in that specific track.
From first dose to 2 years following last dose (up to 30 months)
Duration of Response (DOR)
DOR, computed for all treated participants with a confirmed BOR of CR or PR, is defined as the time between the date of first response and the date of first documented disease progression (as determined by RECIST 1.1) or death due to any cause.
Results are presented by study track. Track 1 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = participants with prior anti-PD-1/PD-L1 therapy Track 4 = participants naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = participants with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
Results for each study track are presented only for treatment groups who received a treatment in that specific track.
From first dose to 2 years following last dose (up to 30 months)
Progression Free Survival Rate (PFSR) at 24 Weeks
The PFSR at 24 weeks is defined as the proportion of treated participants remaining progression free and surviving at 24 weeks since the first dosing date.
Results are presented by study track. Track 1 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 positive (>=1%) Track 2 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 negative (<1%) Track 3 = participants with prior anti-PD-1/PD-L1 therapy Track 4 = participants naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = participants with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
Results for each study track are presented only for treatment groups who received a treatment in that specific track.
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Experiencing Adverse Events (AEs)
This outcome measure describes the percentage of participants who experienced any grade, all causality AEs during the specified time frame
From first dose to 100 days following last dose
Percentage of Participants Experiencing Serious Adverse Events (SAEs)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Advanced Non Small Cell Lung Cancer (NSCLC)
Eastern Cooperative Oncology Group (ECOG) Performance status of ≤ 1
Life expectancy of at least 3 months from most recent chemotherapy or immunotherapy treatment
Must have at least 1 lesion with measurable disease
Exclusion Criteria:
Subjects with certain mutations that have not been treated with a targeted therapy prior to enrollment
Subjects who need daily oxygen therapy
People with autoimmune disease
Other protocol defined inclusion/exclusion criteria could apply
The total number of participants randomized and treated is 295. Each participant was assigned to 1 of 5 non-consecutive Tracks (based on previous therapy exposure and/or PD-1/PD-L1 expression).
14 of the 295 participants, after receiving initial treatment, were re-randomized to a second, different treatment (either under a different Track or within the same Track).
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Nivolumab
Nivolumab monotherapy 240 mg Q2W administered until completion of 6 cycles (1 cycle=4 weeks)
FG001
Nivolumab + Dasatinib
Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
Periods
Title
Milestones
Reasons Not Completed
Track 1
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
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
SAP
No
Yes
No
Statistical Analysis Plan
Nov 1, 2017
Jan 27, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Denmark
Netherlands
Norway
Sweden
United Kingdom
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
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
Nivolumab & Dasatinib
Nivolumab & Ipilimumab
Nivolumab & Relatlimab
BMS-936558
MDX-1106
OPDIVO
Dasatinib
Drug
Nivolumab & Dasatinib
BMS-354825
SPRYCEL
Relatlimab
Biological
Nivolumab & Relatlimab
BMS-986016
Ipilimumab
Biological
Nivolumab & Ipilimumab
BMS-734016
Yervoy
BMS-986205
Drug
Specified dose on specified days
Nivolumab & BMS-986205
From first dose to 24 weeks after first dose
This outcome measure describes the percentage of participants who experienced any grade, all causality SAEs during the specified time frame
From first dose to 100 days following last dose
Percentage of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
This outcome measure describes the percentage of participants who experienced all causality AEs leading to discontinuation of study therapy during the specified time frame
From first dose to 100 days following last dose
Percentage of Participants Experiencing Death
This outcome measure describes the percentage of participants who died (due to any cause) during the specified time frame
From first dose to up to 45 months following first dose
Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests
The following measurements will be considered laboratory abnormalities for hepatic tests:
ALT or AST > 3 x ULN, > 5 x ULN, > 10 x ULN and > 20 x ULN
Total bilirubin > 2 x ULN
Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN
Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN ALT=Alanine aminotransferase AST=Aspartate aminotransferase ULN=Upper Limit of Normal
From first dose to 100 days following last dose (approximately 9 months)
Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests
The following measurements will be considered laboratory abnormalities for thyroid tests:
TSH value > ULN and
With baseline TSH value ≤ ULN
At least one T3/T4 test value < LLN
Low TSH < LLN and
With baseline TSH value ≥ LLN
At least one T3/T4 test value > ULN TSH = thyroid stimulating hormone ULN=Upper Limit of Normal LLN=Lower Limit of Normal T3=Triiodothyronine T4=Thyroxine
From first dose to 100 days following last dose (approximately 9 months)
Los Angeles
California
90033
United States
Cedars-Sinai Medical Center
Los Angeles
California
90048
United States
University of Californa, Los Angeles (UCLA)
Los Angeles
California
90095
United States
Hoag Memorial Hospital Presbyterian
Newport Beach
California
92658
United States
University of California San Diego
San Diego
California
92122
United States
University of Colorado Denver
Aurora
Colorado
80045
United States
Yale Cancer Center
New Haven
Connecticut
06511
United States
University of Kansas Cancer Center
Westwood
Kansas
66205
United States
University of Maryland - Marlene and Stewart Greenebaum Cancer Center
Baltimore
Maryland
21201
United States
Sidney Kimmel Comprehensive Cancer Center
Baltimore
Maryland
21287
United States
Massachusetts General Hospital
Boston
Massachusetts
02114
United States
Beth Israel Deaconess Medical Center
Boston
Massachusetts
02215
United States
Dana Farber/Harvard Cancer Center
Boston
Massachusetts
02215
United States
University of Michigan Health System (UMHS) - University Hospital (University of Michigan Medical Ce
Ann Arbor
Michigan
48109
United States
Karmanos Cancer Institute
Detroit
Michigan
48201
United States
Washington University, The Center for Advanced Medicine
St Louis
Missouri
63110
United States
Comprehensive Cancer Centers of Nevada
Las Vegas
Nevada
89119
United States
Roswell Park Cancer Institute
Buffalo
New York
14263
United States
Memorial Sloan Kettering Cancer Center
New York
New York
10065
United States
Univ of NC Shool of Medicine
Chapel Hill
North Carolina
27514
United States
The Ohio State University
Columbus
Ohio
43210
United States
Northwest Cancer Specialists
Portland
Oregon
97225
United States
Thomas Jefferson University
Philadelphia
Pennsylvania
19107
United States
Fox Chase Cancer Center
Philadelphia
Pennsylvania
19111-2497
United States
University of Pittsburgh Medical Center
Pittsburgh
Pennsylvania
15217
United States
The West Clinic, P.C. d/b/a West Cancer Center
Germantown
Tennessee
38138
United States
Sarah Cannon Cancer Center
Nashville
Tennessee
37203
United States
Sammons Cancer Center (Uso)
Dallas
Texas
75246
United States
Texas Oncology, P.A.
Fort Worth
Texas
76104
United States
The University of Texas MD Anderson Cancer Center
Houston
Texas
77030
United States
Us Oncology
Tyler
Texas
75702
United States
Huntsman Cancer Institute
Salt Lake City
Utah
84112
United States
Virginia Cancer Specialists, PC
Fairfax
Virginia
22031
United States
University of Washington-Seattle Cancer Care Alliance
Seattle
Washington
98109
United States
Local Institution
Clayton
Victoria
Australia
Local Institution
Salzburg
5020
Austria
Juravinski Cancer Centre, Hamilton Health Sciences-Mcmaster Univeristy's Faculty Of Health Sciences
Hamilton
Ontario
L8V 5C2
Canada
University Of Ottawa - The Ottawa Hospital Cancer centre
Nivolumab 240 mg Q2W + BMS986016 20 mg Q2W, administered until completion of 6 cycles (1 cycle=4 weeks)
FG003
Nivolumab + Ipilimumab
Nivolumab 240 mg Q2W for 12 doses + Ipilimumab 1 mg/kg Q6W for 4 doses, administered until completion of 24 weeks of study
FG004
Nivolumab + BMS986205
Nivolumab 480 mg Q4W + BMS986205 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
FG00040 subjects
FG0014 subjects
FG0020 subjects
FG0033 subjects
FG0040 subjects
COMPLETED
FG00013 subjects3 participants were re-randomized to track 3 (2 part.) or track 5 (1 part.)
FG0012 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
NOT COMPLETED
FG00027 subjects
FG0012 subjects
FG0020 subjects
FG0032 subjects
FG0040 subjects
Type
Comment
Reasons
Disease progression
FG00020 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
Adverse event unrelated to study drug
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Study drug toxicity
FG0004 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Participant request to discontinue
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other reasons
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Track 2
Type
Comment
Milestone Data
STARTED
FG0009 subjects
FG0018 subjects
FG0022 subjects
FG00312 subjects
FG0040 subjects
COMPLETED
FG0003 subjects2 participants were re-randomized to track 3 (1 part.) or track 5 (1 part.)
FG0010 subjects
FG0020 subjects
FG0035 subjects
NOT COMPLETED
FG0006 subjects
FG0018 subjects
FG0022 subjects
FG0037 subjects
FG004
Type
Comment
Reasons
Disease progression
FG0004 subjects
FG0015 subjects
FG0022 subjects
FG003
Track 3
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG00141 subjects2 participants had prior treatment in track 1 (1 part.) or track 2 (1 part.)
FG00216 subjects1 participant had prior treatment in track 3
FG00318 subjects5 participants had prior treatment in track 1 (1 part.) or track 3 (4 part.)
FG0040 subjects
COMPLETED
FG0000 subjects
FG0015 subjects6 participants were re-randomized to track 3 (5 part.) or to track 5 (1 part.)
FG0021 subjects
FG0032 subjects
NOT COMPLETED
FG0000 subjects
FG00136 subjects
FG00215 subjects
FG00316 subjects
FG004
Type
Comment
Reasons
Disease progression
FG0000 subjects
FG00124 subjects
FG00213 subjects
FG003
Track 4
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG00153 subjects
FG0020 subjects
FG00360 subjects
FG0040 subjects
COMPLETED
FG0000 subjects
FG0012 subjects1 participant was re-randomized to track 5
FG0020 subjects
FG00318 subjects
NOT COMPLETED
FG0000 subjects
FG00151 subjects
FG0020 subjects
FG00342 subjects
FG004
Type
Comment
Reasons
Study drug toxicity
FG0000 subjects
FG0016 subjects
FG0020 subjects
FG003
Track 5
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00443 subjects6 participants had prior treatment in track 1 (1 part.), 2 (2 part.), 3 (2 part.) or 4 (1 part.)
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Disease progression
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Nivolumab
Nivolumab monotherapy 240 mg Q2W administered until completion of 6 cycles (1 cycle=4 weeks)
BG001
Nivolumab + Dasatinib
Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
BG002
Nivolumab + BMS986016
Nivolumab 240 mg Q2W + BMS986016 20 mg Q2W, administered until completion of 6 cycles (1 cycle=4 weeks)
BG003
Nivolumab + Ipilimumab
Nivolumab 240 mg Q2W for 12 doses + Ipilimumab 1 mg/kg Q6W for 4 doses, administered until completion of 24 weeks of study
BG004
Nivolumab + BMS986205
Nivolumab 480 mg Q4W + BMS986205 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00049
BG001104
BG00217
BG00388
BG00437
BG005295
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00064.5± 10.27
BG00163.6± 9.25
BG00266.6± 9.17
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00021
BG00134
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0012
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
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
Objective Response Rate (ORR)
ORR is defined as the percentage of participants whose confirmed best overall response (BOR) is either a complete response (CR) or partial response (PR). BOR was assessed by investigator per RECIST1.1.
Results are presented by study track. Track 1 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = participants with prior anti-PD-1/PD-L1 therapy Track 4 = participants naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = participants with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
Results for each study track are presented only for treatment groups who received a treatment in that specific track.
All treated participants. 14 participants, after receiving initial treatment, were re-randomized to a second, different treatment. They were analyzed under both groups they received treatment for.
Posted
Number
95% Confidence Interval
Percent of Participants
From first dose to 2 years following last dose (up to 30 months)
ID
Title
Description
OG000
Nivolumab
Nivolumab monotherapy 240 mg Q2W administered until completion of 6 cycles (1 cycle=4 weeks)
OG001
Nivolumab + Dasatinib
Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
OG002
Nivolumab + BMS986016
Nivolumab 240 mg Q2W + BMS986016 20 mg Q2W, administered until completion of 6 cycles (1 cycle=4 weeks)
OG003
Nivolumab + Ipilimumab
Nivolumab 240 mg Q2W for 12 doses + Ipilimumab 1 mg/kg Q6W for 4 doses, administered until completion of 24 weeks of study
OG004
Nivolumab + BMS986205
Nivolumab 480 mg Q4W + BMS986205 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
Units
Counts
Participants
OG00049
OG001106
OG00218
OG003
Title
Denominators
Categories
Study Track 1
ParticipantsOG00040
ParticipantsOG0014
ParticipantsOG0020
ParticipantsOG003
Primary
Duration of Response (DOR)
DOR, computed for all treated participants with a confirmed BOR of CR or PR, is defined as the time between the date of first response and the date of first documented disease progression (as determined by RECIST 1.1) or death due to any cause.
Results are presented by study track. Track 1 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = participants with prior anti-PD-1/PD-L1 therapy Track 4 = participants naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = participants with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
Results for each study track are presented only for treatment groups who received a treatment in that specific track.
All participants with a confirmed best overall response (BOR) of Complete Response (CR) or Partial Response (PR).
Posted
Median
95% Confidence Interval
Months
From first dose to 2 years following last dose (up to 30 months)
ID
Title
Description
OG000
Nivolumab
Nivolumab monotherapy 240 mg Q2W administered until completion of 6 cycles (1 cycle=4 weeks)
OG001
Nivolumab + Dasatinib
Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
Primary
Progression Free Survival Rate (PFSR) at 24 Weeks
The PFSR at 24 weeks is defined as the proportion of treated participants remaining progression free and surviving at 24 weeks since the first dosing date.
Results are presented by study track. Track 1 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 positive (>=1%) Track 2 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 negative (<1%) Track 3 = participants with prior anti-PD-1/PD-L1 therapy Track 4 = participants naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = participants with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
Results for each study track are presented only for treatment groups who received a treatment in that specific track.
All treated participants. 14 participants, after receiving initial treatment, were re-randomized to a second, different treatment. They were analyzed under both groups they received treatment for.
Posted
Number
95% Confidence Interval
Proportion of Participants
From first dose to 24 weeks after first dose
ID
Title
Description
OG000
Nivolumab
Nivolumab monotherapy 240 mg Q2W administered until completion of 6 cycles (1 cycle=4 weeks)
OG001
Nivolumab + Dasatinib
Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
Secondary
Percentage of Participants Experiencing Adverse Events (AEs)
This outcome measure describes the percentage of participants who experienced any grade, all causality AEs during the specified time frame
All treated participants. 14 participants, after receiving initial treatment, were re-randomized to a second, different treatment. They were analyzed under both groups they received treatment for.
Posted
Number
Percent of Participants
From first dose to 100 days following last dose
ID
Title
Description
OG000
Nivolumab
Nivolumab monotherapy 240 mg Q2W administered until completion of 6 cycles (1 cycle=4 weeks)
OG001
Nivolumab + Dasatinib
Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
OG002
Nivolumab + BMS986016
Nivolumab 240 mg Q2W + BMS986016 20 mg Q2W, administered until completion of 6 cycles (1 cycle=4 weeks)
OG003
Nivolumab + Ipilimumab
Nivolumab 240 mg Q2W for 12 doses + Ipilimumab 1 mg/kg Q6W for 4 doses, administered until completion of 24 weeks of study
Secondary
Percentage of Participants Experiencing Serious Adverse Events (SAEs)
This outcome measure describes the percentage of participants who experienced any grade, all causality SAEs during the specified time frame
All treated participants. 14 participants, after receiving initial treatment, were re-randomized to a second, different treatment. They were analyzed under both groups they received treatment for.
Posted
Number
Percent of Participants
From first dose to 100 days following last dose
ID
Title
Description
OG000
Nivolumab
Nivolumab monotherapy 240 mg Q2W administered until completion of 6 cycles (1 cycle=4 weeks)
OG001
Nivolumab + Dasatinib
Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
OG002
Nivolumab + BMS986016
Nivolumab 240 mg Q2W + BMS986016 20 mg Q2W, administered until completion of 6 cycles (1 cycle=4 weeks)
OG003
Nivolumab + Ipilimumab
Nivolumab 240 mg Q2W for 12 doses + Ipilimumab 1 mg/kg Q6W for 4 doses, administered until completion of 24 weeks of study
Secondary
Percentage of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
This outcome measure describes the percentage of participants who experienced all causality AEs leading to discontinuation of study therapy during the specified time frame
All treated participants. 14 participants, after receiving initial treatment, were re-randomized to a second, different treatment. They were analyzed under both groups they received treatment for.
Posted
Number
Percent of Participants
From first dose to 100 days following last dose
ID
Title
Description
OG000
Nivolumab
Nivolumab monotherapy 240 mg Q2W administered until completion of 6 cycles (1 cycle=4 weeks)
OG001
Nivolumab + Dasatinib
Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
OG002
Nivolumab + BMS986016
Nivolumab 240 mg Q2W + BMS986016 20 mg Q2W, administered until completion of 6 cycles (1 cycle=4 weeks)
OG003
Nivolumab + Ipilimumab
Secondary
Percentage of Participants Experiencing Death
This outcome measure describes the percentage of participants who died (due to any cause) during the specified time frame
All treated participants. 14 participants, after receiving initial treatment, were re-randomized to a second, different treatment. They were analyzed under both groups they received treatment for.
Posted
Number
Percent of Participants
From first dose to up to 45 months following first dose
ID
Title
Description
OG000
Nivolumab
Nivolumab monotherapy 240 mg Q2W administered until completion of 6 cycles (1 cycle=4 weeks)
OG001
Nivolumab + Dasatinib
Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
OG002
Nivolumab + BMS986016
Nivolumab 240 mg Q2W + BMS986016 20 mg Q2W, administered until completion of 6 cycles (1 cycle=4 weeks)
OG003
Nivolumab + Ipilimumab
Nivolumab 240 mg Q2W for 12 doses + Ipilimumab 1 mg/kg Q6W for 4 doses, administered until completion of 24 weeks of study
Secondary
Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests
The following measurements will be considered laboratory abnormalities for hepatic tests:
ALT or AST > 3 x ULN, > 5 x ULN, > 10 x ULN and > 20 x ULN
Total bilirubin > 2 x ULN
Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN
Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN ALT=Alanine aminotransferase AST=Aspartate aminotransferase ULN=Upper Limit of Normal
All treated participants with available measurements. 14 participants, after receiving initial treatment, were re-randomized to a second, different treatment. When measurements were available, these participants were analyzed under both groups they received treatment for.
Posted
Number
Participants
From first dose to 100 days following last dose (approximately 9 months)
ID
Title
Description
OG000
Nivolumab
Nivolumab monotherapy 240 mg Q2W administered until completion of 6 cycles (1 cycle=4 weeks)
OG001
Nivolumab + Dasatinib
Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
OG002
Nivolumab + BMS986016
Nivolumab 240 mg Q2W + BMS986016 20 mg Q2W, administered until completion of 6 cycles (1 cycle=4 weeks)
Secondary
Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests
The following measurements will be considered laboratory abnormalities for thyroid tests:
TSH value > ULN and
With baseline TSH value ≤ ULN
At least one T3/T4 test value < LLN
Low TSH < LLN and
With baseline TSH value ≥ LLN
At least one T3/T4 test value > ULN TSH = thyroid stimulating hormone ULN=Upper Limit of Normal LLN=Lower Limit of Normal T3=Triiodothyronine T4=Thyroxine
All treated participants with available measurements. 14 participants, after receiving initial treatment, were re-randomized to a second, different treatment. When measurements were available, these participants were analyzed under both groups they received treatment for.
Posted
Number
Participants
From first dose to 100 days following last dose (approximately 9 months)
ID
Title
Description
OG000
Nivolumab
Nivolumab monotherapy 240 mg Q2W administered until completion of 6 cycles (1 cycle=4 weeks)
OG001
Nivolumab + Dasatinib
Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
OG002
Nivolumab + BMS986016
Nivolumab 240 mg Q2W + BMS986016 20 mg Q2W, administered until completion of 6 cycles (1 cycle=4 weeks)
Time Frame
All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Description
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
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
Track 1 - Nivolumab
Nivolumab monotherapy 240 mg Q2W administered until completion of 6 cycles (1 cycle=4 weeks)
22
40
24
40
38
40
EG001
Track 1 - Nivolumab + Dasatinib
Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
2
4
2
4
4
4
EG002
Track 1 - Nivolumab + Ipilimumab
Nivolumab 240 mg Q2W for 12 doses + Ipilimumab 1 mg/kg Q6W for 4 doses, administered until completion of 24 weeks of study
1
3
0
3
3
3
EG003
Track 2 - Nivolumab
Nivolumab monotherapy 240 mg Q2W administered until completion of 6 cycles (1 cycle=4 weeks)
6
9
4
9
9
9
EG004
Track 2 - Nivolumab + Dasatinib
Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
4
8
5
8
7
8
EG005
Track 2 - Nivolumab + BMS986016
Nivolumab 240 mg Q2W + BMS986016 20 mg Q2W, administered until completion of 6 cycles (1 cycle=4 weeks)
2
2
2
2
2
2
EG006
Track 2 - Nivolumab + Ipilimumab
Nivolumab 240 mg Q2W for 12 doses + Ipilimumab 1 mg/kg Q6W for 4 doses, administered until completion of 24 weeks of study
6
12
5
12
12
12
EG007
Track 3 - Nivolumab + Dasatinib
Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
20
41
17
41
38
41
EG008
Track 3 - Nivolumab + BMS986016
Nivolumab 240 mg Q2W + BMS986016 20 mg Q2W, administered until completion of 6 cycles (1 cycle=4 weeks)
10
16
9
16
16
16
EG009
Track 3 - Nivolumab + Ipilimumab
Nivolumab 240 mg Q2W for 12 doses + Ipilimumab 1 mg/kg Q6W for 4 doses, administered until completion of 24 weeks of study
9
18
10
18
17
18
EG010
Track 4 - Nivolumab + Dasatinib
Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
33
53
33
53
50
53
EG011
Track 4 - Nivolumab + Ipilimumab
Nivolumab 240 mg Q2W for 12 doses + Ipilimumab 1 mg/kg Q6W for 4 doses, administered until completion of 24 weeks of study
27
60
39
60
59
60
EG012
Track 5 - Nivolumab + BMS986205
Nivolumab 480 mg Q4W + BMS986205 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
27
43
26
43
41
43
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Neutropenia
Blood and lymphatic system disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG0030 affected9 at risk
EG0040 affected8 at risk
EG0050 affected2 at risk
EG0060 affected12 at risk
EG0070 affected41 at risk
EG0080 affected16 at risk
EG0090 affected18 at risk
EG0100 affected53 at risk
EG0111 affected60 at risk
EG0121 affected43 at risk
Atrial fibrillation
Cardiac disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Atrial flutter
Cardiac disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Cardiac arrest
Cardiac disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Cardiac tamponade
Cardiac disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Myocarditis
Cardiac disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Pericardial effusion
Cardiac disorders
22.1
Systematic Assessment
EG0003 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Tachycardia
Cardiac disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Adrenal insufficiency
Endocrine disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hypoparathyroidism
Endocrine disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hypophysitis
Endocrine disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Vision blurred
Eye disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Visual impairment
Eye disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Colitis
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Oesophageal food impaction
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Peritoneal haemorrhage
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Euthanasia
General disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Fatigue
General disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
General physical health deterioration
General disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Influenza like illness
General disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Oedema peripheral
General disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Pain
General disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Pyrexia
General disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hepatitis
Hepatobiliary disorders
22.1
Systematic Assessment
EG0002 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Appendicitis
Infections and infestations
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Brain abscess
Infections and infestations
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Clostridium difficile colitis
Infections and infestations
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Enterocolitis infectious
Infections and infestations
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Influenza
Infections and infestations
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Pneumonia
Infections and infestations
22.1
Systematic Assessment
EG0002 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Pneumonia bacterial
Infections and infestations
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Post procedural infection
Infections and infestations
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Respiratory tract infection
Infections and infestations
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Sepsis
Infections and infestations
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Septic shock
Infections and infestations
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Staphylococcal infection
Infections and infestations
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Fall
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Overdose
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Toxicity to various agents
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Blood bilirubin increased
Investigations
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Blood creatine phosphokinase increased
Investigations
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Human chorionic gonadotropin positive
Investigations
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Transaminases increased
Investigations
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0002 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Osteolysis
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Sjogren's syndrome
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG00010 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Malignant pleural effusion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Metastases to meninges
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Second primary malignancy
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Brachial plexopathy
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Cerebral ischaemia
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Cerebrovascular accident
Nervous system disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Dizziness
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Facial paralysis
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Headache
Nervous system disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Ischaemic stroke
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Polyneuropathy
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Seizure
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Spinal cord compression
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Confusional state
Psychiatric disorders
22.1
Systematic Assessment
EG0002 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Delirium
Psychiatric disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Mental status changes
Psychiatric disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Acute kidney injury
Renal and urinary disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Scrotal oedema
Reproductive system and breast disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Bronchial obstruction
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0002 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0002 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Lung consolidation
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Oesophagobronchial fistula
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0002 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0003 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0004 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Stevens-Johnson syndrome
Skin and subcutaneous tissue disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Deep vein thrombosis
Vascular disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hypotension
Vascular disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Orthostatic hypotension
Vascular disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Superior vena cava syndrome
Vascular disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
22.1
Systematic Assessment
EG0007 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG0031 affected9 at risk
EG0043 affected8 at risk
EG0050 affected2 at risk
EG0063 affected12 at risk
EG0076 affected41 at risk
EG0082 affected16 at risk
EG0091 affected18 at risk
EG01015 affected53 at risk
EG01110 affected60 at risk
EG0126 affected43 at risk
Leukocytosis
Blood and lymphatic system disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
22.1
Systematic Assessment
EG0002 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Arrhythmia
Cardiac disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Atrial fibrillation
Cardiac disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Bradycardia
Cardiac disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Cardiac tamponade
Cardiac disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Tachycardia
Cardiac disorders
22.1
Systematic Assessment
EG0002 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Vertigo
Ear and labyrinth disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hyperthyroidism
Endocrine disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hypophysitis
Endocrine disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Hypothyroidism
Endocrine disorders
22.1
Systematic Assessment
EG0004 affected40 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Thyroiditis
Endocrine disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Cataract
Eye disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Eye pain
Eye disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Vision blurred
Eye disorders
22.1
Systematic Assessment
EG0003 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Visual acuity reduced
Eye disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Visual impairment
Eye disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Vitreous floaters
Eye disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Abdominal distension
Gastrointestinal disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
22.1
Systematic Assessment
EG0005 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
22.1
Systematic Assessment
EG0002 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Anal incontinence
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Ascites
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Autoimmune colitis
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Colitis
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
22.1
Systematic Assessment
EG0009 affected40 at risk
EG0013 affected4 at risk
EG0023 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
22.1
Systematic Assessment
EG00013 affected40 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Dry mouth
Gastrointestinal disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
22.1
Systematic Assessment
EG0002 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Dysphagia
Gastrointestinal disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Faeces discoloured
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Flatulence
Gastrointestinal disorders
22.1
Systematic Assessment
EG0002 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
22.1
Systematic Assessment
EG00014 affected40 at risk
EG0013 affected4 at risk
EG0022 affected3 at risk
EG003
Oesophageal mucosa erythema
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Oesophagitis
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Pancreatitis
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Peritoneal haemorrhage
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Stomatitis
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Tongue dysplasia
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Toothache
Gastrointestinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
22.1
Systematic Assessment
EG0008 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Asthenia
General disorders
22.1
Systematic Assessment
EG0005 affected40 at risk
EG0012 affected4 at risk
EG0020 affected3 at risk
EG003
Chest discomfort
General disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Chest pain
General disorders
22.1
Systematic Assessment
EG0003 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Chills
General disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Early satiety
General disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Face oedema
General disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Fatigue
General disorders
22.1
Systematic Assessment
EG00016 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Influenza like illness
General disorders
22.1
Systematic Assessment
EG0002 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Malaise
General disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Mucosal inflammation
General disorders
22.1
Systematic Assessment
EG0002 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Non-cardiac chest pain
General disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Oedema
General disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0012 affected4 at risk
EG0020 affected3 at risk
EG003
Oedema peripheral
General disorders
22.1
Systematic Assessment
EG0007 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Pain
General disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Pyrexia
General disorders
22.1
Systematic Assessment
EG0003 affected40 at risk
EG0012 affected4 at risk
EG0020 affected3 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hepatic failure
Hepatobiliary disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Jaundice
Hepatobiliary disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hypersensitivity
Immune system disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Seasonal allergy
Immune system disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Abscess
Infections and infestations
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Bronchitis
Infections and infestations
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Candida infection
Infections and infestations
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Conjunctivitis
Infections and infestations
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Cystitis
Infections and infestations
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0011 affected4 at risk
EG0021 affected3 at risk
EG003
Diverticulitis
Infections and infestations
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Eye infection
Infections and infestations
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Influenza
Infections and infestations
22.1
Systematic Assessment
EG0002 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Laryngitis
Infections and infestations
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Lung abscess
Infections and infestations
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Nasopharyngitis
Infections and infestations
22.1
Systematic Assessment
EG0002 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Oral candidiasis
Infections and infestations
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Otitis externa
Infections and infestations
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Pneumonia
Infections and infestations
22.1
Systematic Assessment
EG0002 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Rhinitis
Infections and infestations
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Sinusitis
Infections and infestations
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Upper respiratory tract infection
Infections and infestations
22.1
Systematic Assessment
EG0002 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
22.1
Systematic Assessment
EG0007 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Contusion
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Fall
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
22.1
Systematic Assessment
EG0002 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Amylase increased
Investigations
22.1
Systematic Assessment
EG0003 affected40 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
22.1
Systematic Assessment
EG0004 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Blood alkaline phosphatase increased
Investigations
22.1
Systematic Assessment
EG0003 affected40 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Blood bilirubin increased
Investigations
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Blood calcium increased
Investigations
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Blood creatine phosphokinase increased
Investigations
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Blood creatinine increased
Investigations
22.1
Systematic Assessment
EG0002 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Blood phosphorus decreased
Investigations
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Blood thyroid stimulating hormone decreased
Investigations
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
22.1
Systematic Assessment
EG0002 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Blood urea increased
Investigations
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Body temperature increased
Investigations
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
C-reactive protein increased
Investigations
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
CD4 lymphocytes decreased
Investigations
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Electrocardiogram QT prolonged
Investigations
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Lipase increased
Investigations
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0011 affected4 at risk
EG0021 affected3 at risk
EG003
Lymphocyte count decreased
Investigations
22.1
Systematic Assessment
EG0002 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Neutrophil count decreased
Investigations
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Transaminases increased
Investigations
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Troponin T increased
Investigations
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Weight decreased
Investigations
22.1
Systematic Assessment
EG0007 affected40 at risk
EG0012 affected4 at risk
EG0021 affected3 at risk
EG003
Weight increased
Investigations
22.1
Systematic Assessment
EG0002 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
White blood cell count increased
Investigations
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
22.1
Systematic Assessment
EG00016 affected40 at risk
EG0011 affected4 at risk
EG0021 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Fluid retention
Metabolism and nutrition disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Hyperamylasaemia
Metabolism and nutrition disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
22.1
Systematic Assessment
EG0002 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
22.1
Systematic Assessment
EG0003 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
22.1
Systematic Assessment
EG0003 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
22.1
Systematic Assessment
EG0004 affected40 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
22.1
Systematic Assessment
EG0005 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
22.1
Systematic Assessment
EG0003 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Sodium retention
Metabolism and nutrition disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG00012 affected40 at risk
EG0011 affected4 at risk
EG0021 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0009 affected40 at risk
EG0012 affected4 at risk
EG0021 affected3 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0002 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Joint range of motion decreased
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0003 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0007 affected40 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0002 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0004 affected40 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0007 affected40 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Soft tissue swelling
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
22.1
Systematic Assessment
EG0002 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Balance disorder
Nervous system disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Brain oedema
Nervous system disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Dizziness
Nervous system disorders
22.1
Systematic Assessment
EG0006 affected40 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Dizziness postural
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Dysgeusia
Nervous system disorders
22.1
Systematic Assessment
EG0002 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Headache
Nervous system disorders
22.1
Systematic Assessment
EG00011 affected40 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Hemiparesis
Nervous system disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hepatic encephalopathy
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hypoaesthesia
Nervous system disorders
22.1
Systematic Assessment
EG0003 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Neuropathy peripheral
Nervous system disorders
22.1
Systematic Assessment
EG0002 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Paraesthesia
Nervous system disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Sciatica
Nervous system disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Taste disorder
Nervous system disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Affect lability
Psychiatric disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Anxiety
Psychiatric disorders
22.1
Systematic Assessment
EG0006 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Confusional state
Psychiatric disorders
22.1
Systematic Assessment
EG0003 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Depression
Psychiatric disorders
22.1
Systematic Assessment
EG0002 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Insomnia
Psychiatric disorders
22.1
Systematic Assessment
EG0007 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Acute kidney injury
Renal and urinary disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Dysuria
Renal and urinary disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Haematuria
Renal and urinary disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Leukocyturia
Renal and urinary disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Nocturia
Renal and urinary disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Renal failure
Renal and urinary disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Urinary retention
Renal and urinary disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Genital lesion
Reproductive system and breast disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG00010 affected40 at risk
EG0011 affected4 at risk
EG0021 affected3 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0002 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG00014 affected40 at risk
EG0013 affected4 at risk
EG0020 affected3 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0002 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0005 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Paranasal sinus discomfort
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0002 affected40 at risk
EG0012 affected4 at risk
EG0020 affected3 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0007 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
22.1
Systematic Assessment
EG0004 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Hair growth abnormal
Skin and subcutaneous tissue disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
22.1
Systematic Assessment
EG0002 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
22.1
Systematic Assessment
EG0006 affected40 at risk
EG0011 affected4 at risk
EG0021 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
22.1
Systematic Assessment
EG0005 affected40 at risk
EG0011 affected4 at risk
EG0022 affected3 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
22.1
Systematic Assessment
EG0002 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
22.1
Systematic Assessment
EG0001 affected40 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Skin burning sensation
Skin and subcutaneous tissue disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Skin hypopigmentation
Skin and subcutaneous tissue disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Deep vein thrombosis
Vascular disorders
22.1
Systematic Assessment
EG0002 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hot flush
Vascular disorders
22.1
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hypertension
Vascular disorders
22.1
Systematic Assessment
EG0002 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hypotension
Vascular disorders
22.1
Systematic Assessment
EG0002 affected40 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
This study was terminated early by sponsor for reasons unrelated to safety.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.