A Study to Investigate the Efficacy and Safety of Cobimet... | NCT03264066 | Trialant
NCT03264066
Sponsor
Hoffmann-La Roche
Status
Completed
Last Update Posted
May 11, 2021Actual
Enrollment
87Actual
Phase
Phase 2
Conditions
Solid Tumors
Interventions
Cobimetinib
Atezolizumab
Atezolizumab Cohort 7
Countries
United States
Belgium
Germany
Hungary
South Korea
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03264066
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
WO39760
Secondary IDs
ID
Type
Description
Link
2017-000794-37
EudraCT Number
Brief Title
A Study to Investigate the Efficacy and Safety of Cobimetinib Plus Atezolizumab in Participants With Solid Tumors
Official Title
A Phase II, Open-Label, Multicenter, Multicohort Study to Investigate the Efficacy and Safety of Cobimetinib Plus Atezolizumab in Patients With Solid Tumors
Acronym
Not provided
Organization
Hoffmann-La RocheINDUSTRY
Status Module
Record Verification Date
Apr 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 23, 2017Actual
Primary Completion Date
Jun 25, 2020Actual
Completion Date
Jun 25, 2020Actual
First Submitted Date
Aug 17, 2017
First Submission Date that Met QC Criteria
Aug 24, 2017
First Posted Date
Aug 28, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Dec 23, 2020
Results First Submitted that Met QC Criteria
Feb 9, 2021
Results First Posted Date
Mar 1, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jun 16, 2020
Certification/Extension First Submitted that Passed QC Review
Feb 9, 2021
Certification/Extension First Posted Date
Mar 1, 2021Actual
Last Update Submitted Date
Apr 20, 2021
Last Update Posted Date
May 11, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Hoffmann-La RocheINDUSTRY
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 study to evaluate the efficacy, safety, and pharmacokinetics of cobimetinib plus atezolizumab in participants with advanced solid tumors including the following cohorts: squamous cell carcinoma of the head and neck (SCCHN), urothelial carcinoma (UC), and renal cell carcinoma (RCC).
Detailed Description
Not provided
Conditions Module
Conditions
Solid Tumors
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
87Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1 - SCCHN - Treatment Naive
Experimental
In participants with recurrent or advanced / metastatic SSCHN who are anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib will be administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
Drug: Cobimetinib
Drug: Atezolizumab
Cohort 2 - UC - Treatment Naive
Experimental
In participants with advanced / metastatic UC who are anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib will be administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
Drug: Cobimetinib
Drug: Atezolizumab
Cohort 3 - RCC - Treatment Naive
Experimental
In participants with metastatic RCC who are anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib will be administered at the approved dose and schedule of 60 milligrams (mg) once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
Drug: Cobimetinib
Drug: Atezolizumab
Cohort 4 - SCCHN - Previous Treatment Exposure
Experimental
In participants with SCCHN whose disease has progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib will be administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Cobimetinib
Drug
Participants will receive cobimetinib 60 mg (3 tablets of 20 mg each) orally once a day on Days 1-21 of each 28-day cycle.
Cohort 1 - SCCHN - Treatment Naive
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Objective Response Rate (ORR)
Objective response rate was defined as the percentage of participants with a complete response (CR) or a partial response (PR) on two consecutive tumor assessments ≥4 weeks apart, as determined by the investigators using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). CR was defined as disappearance of all lesions. PR was defined as ≥30% decrease in the sum of diameters of target lesions, in the absence of CR, new lesions, and unequivocal progression in non-target lesions.
Up to approximately 31 months
Secondary Outcomes
Measure
Description
Time Frame
Overall Survival (OS)
Overall survival was defined as the time from enrollment to death from any cause. The median for OS is Kaplan-Meier estimate. 95% CI for median was computed using the method of Brookmeyer and Crowley.
Up to approximately 31 months
Progression-Free Survival (PFS)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
General Inclusion Criteria:
Age ≥18 years
Ability to comply with the study protocol, in the investigator's judgment
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Life expectancy ≥3 months, as determined by the investigator
Adequate hematologic and end-organ function
Cancer-Related Inclusion Criteria:
Patients must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) scan per RECIST v1.1.
Availability to provide a representative tumor specimen biopsy
Evidence of tumor progression on or after the last treatment regimen received and within 6 months prior to study enrollment
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a non-hormonal contraceptive method with a failure rate of <1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab and within 3 months after the last dose of cobimetinib
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm during the treatment period and for at least 3 months after the last dose of cobimetinib
Exclusion Criteria:
General Exclusion Criteria:
Inability to swallow medications
Malabsorption condition that would alter the absorption of orally administered medications
Poor peripheral venous access
Prior treatment with cobimetinib or a MEK inhibitor
Prior treatment with T-cell co-stimulating or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
Treatment with investigational therapy within 14 days prior to initiation of study treatment
Any anti-cancer therapy, including chemotherapy or hormonal therapy, within 2 weeks prior to initiation of study treatment
History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
Known hypersensitivity to biopharmaceutical agents produced in Chinese hamster ovary cells or any component of the atezolizumab formulation, or any component of the cobimetinib formulation
History of serous retinopathy, retinal vein occlusion (RVO), or evidence of ongoing serous retinopathy or RVO at baseline
Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
Uncontrolled tumor-related pain
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage more than once every 28 days
Uncontrolled hypercalcemia (ionized calcium >1.5 millimoles per liter [mmol/L], calcium >12 milligrams per deciliter [mg/dL], or corrected calcium greater than the upper limit of normal [ULN]) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
Active or untreated central nervous system (CNS) metastases
Pregnancy or breastfeeding, or intending to become pregnant during the study
Exclusion Criteria based on Organ Function or Medical History
Cardiovascular
Patients who meet the following cardiovascular exclusion criterion will be excluded from study entry:
Left ventricular ejection fraction (LVEF) below the institutional lower limit of normal or <50%, whichever is lower
Infections Patients who meet any of the following infection exclusion criteria will be excluded from study entry:
Positive human immunodeficiency virus (HIV) test at screening
Active hepatitis B virus (HBV) infection (chronic or acute)
Active hepatitis C virus (HCV) infection
Active tuberculosis
Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Clinical Trials
Hoffmann-La Roche
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Georgetown University Medical Center
Washington D.C.
District of Columbia
20007
United States
Kansas City - Menorah Medical Center
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Participants with advanced solid tumors were included in the study: squamous cell carcinoma of head and neck (SCCHN), urothelial carcinoma (UC), and renal cell carcinoma (RCC).
Recruitment Details
Enrollment took place in six countries: Republic of Korea, Belgium, Germany, United Kingdom, Hungary and United States. No participants were enrolled in Cohort 7. Participants in long term follow up and who continued to receive treatment(s) in a post-trial access program are designated in Participant Flow as "Study terminated by Sponsor".
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 1 - SCCHN - Treatment Naive
In participants with recurrent or advanced / metastatic squamous cell carcinoma of the head and neck (SSCHN) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
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_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Sep 18, 2018
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: Cobimetinib
Drug: Atezolizumab
Cohort 5 - UC - Previous Treatment Exposure
Experimental
In participants with UC whose disease has progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib will be administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
Drug: Cobimetinib
Drug: Atezolizumab
Cohort 6 - RCC - Previous Treatment Exposure
Experimental
In participants with RCC whose disease has progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib will be administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
Drug: Cobimetinib
Drug: Atezolizumab
Cohort 7 - Biopsy Cohort
Experimental
In participants with solid non-melanoma, non- hematologic tumors who previously developed primary or secondary resistance to an anti-PD-1 or anti-PD-L1 agent, cobimetinib will be administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle. The first dose of atezolizumab of 840 mg by IV infusions on Day 15 of Cycle 1. Thereafter, they will receive atezolizumab 840 mg IV infusion Q2W on Days 1 and 15 of Cycle 2 and all subsequent cycles.
Drug: Cobimetinib
Drug: Atezolizumab Cohort 7
Cohort 2 - UC - Treatment Naive
Cohort 3 - RCC - Treatment Naive
Cohort 4 - SCCHN - Previous Treatment Exposure
Cohort 5 - UC - Previous Treatment Exposure
Cohort 6 - RCC - Previous Treatment Exposure
Cohort 7 - Biopsy Cohort
Cotellic
Atezolizumab
Drug
Atezolizumab will be given at a fixed dose of 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
Cohort 1 - SCCHN - Treatment Naive
Cohort 2 - UC - Treatment Naive
Cohort 3 - RCC - Treatment Naive
Cohort 4 - SCCHN - Previous Treatment Exposure
Cohort 5 - UC - Previous Treatment Exposure
Cohort 6 - RCC - Previous Treatment Exposure
Tecentriq
Atezolizumab Cohort 7
Drug
Only for participants in cohort 7, the first dose of atezolizumab of 840 mg will be given by IV infusion on Day 15 of Cycle 1; thereafter, they will receive atezolizumab 840 mg IV infusion Q2W on Days 1 and 15 of Cycle 2 and all subsequent cycles.
Cohort 7 - Biopsy Cohort
Tecentriq
PFS was defined as the time from enrollment to the first occurrence of disease progression as determined by the investigator(s), using RECIST v1.1, or to death from any cause, whichever occurs first. Disease progression was defined as ≥20% increase in in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions.
Up to approximately 31 months
Duration of Response (DOR)
DOR was defined as the time from the first occurrence of a documented, confirmed objective response to disease progression as determined by the investigator, using RECIST v1.1, or to death from any cause, whichever occurs first. Objective response was defined as a complete response (CR) or a partial response (PR) on two consecutive tumor assessments ≥4 weeks apart. CR was defined as disappearance of all lesions. PR was defined as ≥30% decrease in the sum of diameters of target lesions, in the absence of CR, new lesions, and unequivocal progression in non-target lesions. Disease progression was defined as ≥20% increase in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions. Presented here is median DOR at the time of primary analysis. The median for the duration of response is Kaplan-Meier estimate. 95% CI for median was computed using the method of Brookmeyer and Crowley.
Up to approximately 22 months
Disease Control Rate (DCR)
DCR was defined as the percentage of participants with a complete response (CR), a partial response (PR), or stable disease at 16 weeks as determined by the investigator using RECIST v1.1. CR was defined as disappearance of all lesions. PR was defined as ≥30% decrease in the sum of diameters of target lesions, in the absence of CR, new lesions, and unequivocal progression in non-target lesions. Stable disease was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for disease progression. Disease progression was defined as ≥20% increase in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions.
At 16 weeks
Number of Participants With Adverse Events
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Up to approximately 31 months
Maximum Plasma Concentration (Cmax) of Cobimetinib
Cmax is the maximum (or peak) concentration that a study drug achieves in the body.
Day 15 of Cycle 3 (cycle is 28 days): 2-4 hours after cobimetinib dose
Minimum Plasma Concentration (Cmin) of Cobimetinib
Cmin is the minimum (or trough) concentration that a study drug achieves in the body.
Day 15 of Cycle 3 (cycle is 28 days): prior to cobimetinib dose
Maximum Serum Concentration (Cmax) of Atezolizumab
Cmax is the maximum (or peak) concentration that a study drug achieves in the body.
30 minutes following end of atezolizumab infusion on Day 15 of Cycle 3 (each cycle is 28 days)
Minimum Serum Concentration (Cmin) of Atezolizumab
Cmin is the minimum (or trough) concentration that a study drug achieves in the body.
Prior to atezolizumab infusion on Day 1 of Cycles (each cycle is 28 days) 2, 4, 8, 12, and 16, Day 15 of Cycle 3
Number of Participants With Anti-drug Antibodies (ADAs)
Participants were considered to be ADA positive if they were missing data at baseline but developed an ADA response following study drug administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was at least 4-fold greater (i.e., ≥0.60-titer units) than the titer of the baseline sample (treatment-enhanced ADA response). Participants were considered to be ADA negative if they were missing data at baseline, had a post-baseline ADA result, and all post-baseline samples were negative, or if they were ADA positive at baseline but did not have any post-baseline samples with a titer that was at least 4-fold greater than the titer of the baseline sample (treatment unaffected).
Day 1 of Cycles (each cycle is 28 days) 1, 2, 4, 8, 12, and 16; Day 15 of Cycle 3; at atezolizumab treatment discontinuation visit, and <90 days after last atezolizumab infusion (up to approximately 31 months)
Kansas City
Kansas
66209
United States
Memorial Sloan-Kettering Cancer Center
Commack
New York
11725
United States
Memorial Sloan Kettering - Basking Ridge
New York
New York
10065
United States
Memorial Sloan Kettering Cancer Center
New York
New York
10065
United States
Sarah Cannon Research Institute
Nashville
Tennessee
37203
United States
AZ Groeninge
Kortrijk
8500
Belgium
Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen
In participants with advanced / metastatic urothelial carcinoma (UC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
FG002
Cohort 3 - RCC - Treatment Naive
In participants with metastatic renal cell carcinoma (RCC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
FG003
Cohort 4 - SCCHN - Previous Treatment Exposure
In participants with SCCHN whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
FG004
Cohort 5 - UC - Previous Treatment Exposure
In participants with UC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
FG005
Cohort 6 - RCC - Previous Treatment Exposure
In participants with RCC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
FG00020 subjects
FG00120 subjects
FG00217 subjects
FG00320 subjects
FG0047 subjects
FG0053 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
NOT COMPLETED
FG00020 subjects
FG00120 subjects
FG00217 subjects
FG00320 subjects
FG0047 subjects
FG0053 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Death
FG00012 subjects
FG00112 subjects
FG0028 subjects
FG00310 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Progressive Disease
FG0000 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
FG004
Study Terminated by Sponsor
FG0005 subjects
FG0015 subjects
FG0028 subjects
FG0035 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0035 subjects
FG004
The intent-to-treat (ITT) population included all participants enrolled in the study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1 - SCCHN - Treatment Naive
In participants with recurrent or advanced / metastatic squamous cell carcinoma of the head and neck (SSCHN) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
BG001
Cohort 2 - UC - Treatment Naive
In participants with advanced / metastatic urothelial carcinoma (UC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
BG002
Cohort 3 - RCC - Treatment Naive
In participants with metastatic renal cell carcinoma (RCC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
BG003
Cohort 4 - SCCHN - Previous Treatment Exposure
In participants with SCCHN whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
BG004
Cohort 5 - UC - Previous Treatment Exposure
In participants with UC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
BG005
Cohort 6 - RCC - Previous Treatment Exposure
In participants with RCC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00020
BG00120
BG00217
BG00320
BG0047
BG0053
BG00687
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
Adults (18-64 years)
BG00012
BG0016
BG00210
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0018
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
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)
Objective response rate was defined as the percentage of participants with a complete response (CR) or a partial response (PR) on two consecutive tumor assessments ≥4 weeks apart, as determined by the investigators using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). CR was defined as disappearance of all lesions. PR was defined as ≥30% decrease in the sum of diameters of target lesions, in the absence of CR, new lesions, and unequivocal progression in non-target lesions.
The intent-to-treat (ITT) population included all participants enrolled in the study.
Posted
Number
95% Confidence Interval
percentage of participants
Up to approximately 31 months
ID
Title
Description
OG000
Cohort 1 - SCCHN - Treatment Naive
In participants with recurrent or advanced / metastatic squamous cell carcinoma of the head and neck (SSCHN) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
OG001
Cohort 2 - UC - Treatment Naive
In participants with advanced / metastatic urothelial carcinoma (UC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
OG002
Cohort 3 - RCC - Treatment Naive
In participants with metastatic renal cell carcinoma (RCC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
OG003
Cohort 4 - SCCHN - Previous Treatment Exposure
In participants with SCCHN whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
OG004
Cohort 5 - UC - Previous Treatment Exposure
In participants with UC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
OG005
Cohort 6 - RCC - Previous Treatment Exposure
In participants with RCC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
Units
Counts
Participants
OG00020
OG00120
OG00217
OG003
Title
Denominators
Categories
Title
Measurements
OG00020.0(0.00 to 40.03)
OG00130.0(7.42 to 52.58)
OG00217.6(0.00 to 38.71)
OG003
Secondary
Overall Survival (OS)
Overall survival was defined as the time from enrollment to death from any cause. The median for OS is Kaplan-Meier estimate. 95% CI for median was computed using the method of Brookmeyer and Crowley.
The ITT population included all participants enrolled in the study.
Posted
Median
95% Confidence Interval
months
Up to approximately 31 months
ID
Title
Description
OG000
Cohort 1 - SCCHN - Treatment Naive
In participants with recurrent or advanced / metastatic squamous cell carcinoma of the head and neck (SSCHN) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
OG001
Cohort 2 - UC - Treatment Naive
In participants with advanced / metastatic urothelial carcinoma (UC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
OG002
Cohort 3 - RCC - Treatment Naive
Secondary
Progression-Free Survival (PFS)
PFS was defined as the time from enrollment to the first occurrence of disease progression as determined by the investigator(s), using RECIST v1.1, or to death from any cause, whichever occurs first. Disease progression was defined as ≥20% increase in in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions.
The ITT population included all participants enrolled in the study.
Posted
Median
Full Range
months
Up to approximately 31 months
ID
Title
Description
OG000
Cohort 1 - SCCHN - Treatment Naive
In participants with recurrent or advanced / metastatic squamous cell carcinoma of the head and neck (SSCHN) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
OG001
Cohort 2 - UC - Treatment Naive
In participants with advanced / metastatic urothelial carcinoma (UC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
Secondary
Duration of Response (DOR)
DOR was defined as the time from the first occurrence of a documented, confirmed objective response to disease progression as determined by the investigator, using RECIST v1.1, or to death from any cause, whichever occurs first. Objective response was defined as a complete response (CR) or a partial response (PR) on two consecutive tumor assessments ≥4 weeks apart. CR was defined as disappearance of all lesions. PR was defined as ≥30% decrease in the sum of diameters of target lesions, in the absence of CR, new lesions, and unequivocal progression in non-target lesions. Disease progression was defined as ≥20% increase in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions. Presented here is median DOR at the time of primary analysis. The median for the duration of response is Kaplan-Meier estimate. 95% CI for median was computed using the method of Brookmeyer and Crowley.
ITT population: all participants enrolled in the study. Median DOR is presented at the time of primary analysis. DOR analyses were not performed at final analysis because Kaplan-Meier was not estimable at primary analysis due to too few events in Cohorts 1 and 3. There were no subsequent events in Cohorts 1 and 3. Cohorts 4-6 had no events.
Posted
Median
95% Confidence Interval
days
Up to approximately 22 months
ID
Title
Description
OG000
Cohort 1 - SCCHN - Treatment Naive
In participants with recurrent or advanced / metastatic squamous cell carcinoma of the head and neck (SSCHN) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
Secondary
Disease Control Rate (DCR)
DCR was defined as the percentage of participants with a complete response (CR), a partial response (PR), or stable disease at 16 weeks as determined by the investigator using RECIST v1.1. CR was defined as disappearance of all lesions. PR was defined as ≥30% decrease in the sum of diameters of target lesions, in the absence of CR, new lesions, and unequivocal progression in non-target lesions. Stable disease was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for disease progression. Disease progression was defined as ≥20% increase in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions.
The ITT population included all participants enrolled in the study.
Posted
Number
95% Confidence Interval
percentage of participants
At 16 weeks
ID
Title
Description
OG000
Cohort 1 - SCCHN - Treatment Naive
In participants with recurrent or advanced / metastatic squamous cell carcinoma of the head and neck (SSCHN) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
OG001
Cohort 2 - UC - Treatment Naive
In participants with advanced / metastatic urothelial carcinoma (UC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
Secondary
Number of Participants With Adverse Events
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
The safety population included all enrolled participants who received at least one dose of study drug.
Posted
Number
participants
Up to approximately 31 months
ID
Title
Description
OG000
Cohort 1 - SCCHN - Treatment Naive
In participants with recurrent or advanced / metastatic squamous cell carcinoma of the head and neck (SSCHN) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
OG001
Cohort 2 - UC - Treatment Naive
In participants with advanced / metastatic urothelial carcinoma (UC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
Secondary
Maximum Plasma Concentration (Cmax) of Cobimetinib
Cmax is the maximum (or peak) concentration that a study drug achieves in the body.
Pharmacokinetic (PK) analysis population consisted of participants with sufficient data to enable estimation of key parameters, with participants grouped according to treatment received.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram per milliliter (ng/mL)
Day 15 of Cycle 3 (cycle is 28 days): 2-4 hours after cobimetinib dose
ID
Title
Description
OG000
Cohorts 1-6
In all participants cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
Units
Counts
Participants
OG000
Secondary
Minimum Plasma Concentration (Cmin) of Cobimetinib
Cmin is the minimum (or trough) concentration that a study drug achieves in the body.
PK analysis population consisted of participants with sufficient data to enable estimation of key parameters, with participants grouped according to treatment received.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Day 15 of Cycle 3 (cycle is 28 days): prior to cobimetinib dose
ID
Title
Description
OG000
Cohorts 1-6
In all participants cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
Units
Counts
Participants
OG000
Secondary
Maximum Serum Concentration (Cmax) of Atezolizumab
Cmax is the maximum (or peak) concentration that a study drug achieves in the body.
PK analysis population consisted of participants with sufficient data to enable estimation of key parameters, with participants grouped according to treatment received.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
30 minutes following end of atezolizumab infusion on Day 15 of Cycle 3 (each cycle is 28 days)
ID
Title
Description
OG000
Cohorts 1-6
In all participants cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
Units
Counts
Participants
OG000
Secondary
Minimum Serum Concentration (Cmin) of Atezolizumab
Cmin is the minimum (or trough) concentration that a study drug achieves in the body.
PK analysis population consisted of participants with sufficient data to enable estimation of key parameters, with participants grouped according to treatment received.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Prior to atezolizumab infusion on Day 1 of Cycles (each cycle is 28 days) 2, 4, 8, 12, and 16, Day 15 of Cycle 3
ID
Title
Description
OG000
Cohorts 1-6
In all participants cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
Units
Counts
Participants
OG000
Secondary
Number of Participants With Anti-drug Antibodies (ADAs)
Participants were considered to be ADA positive if they were missing data at baseline but developed an ADA response following study drug administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was at least 4-fold greater (i.e., ≥0.60-titer units) than the titer of the baseline sample (treatment-enhanced ADA response). Participants were considered to be ADA negative if they were missing data at baseline, had a post-baseline ADA result, and all post-baseline samples were negative, or if they were ADA positive at baseline but did not have any post-baseline samples with a titer that was at least 4-fold greater than the titer of the baseline sample (treatment unaffected).
The safety population included all enrolled participants who received at least one dose of study drug. Number analyzed is the number of participants with data available for analysis.
Posted
Count of Participants
Participants
Day 1 of Cycles (each cycle is 28 days) 1, 2, 4, 8, 12, and 16; Day 15 of Cycle 3; at atezolizumab treatment discontinuation visit, and <90 days after last atezolizumab infusion (up to approximately 31 months)
ID
Title
Description
OG000
Cohort 1 - SCCHN - Treatment Naive
In participants with recurrent or advanced / metastatic squamous cell carcinoma of the head and neck (SSCHN) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
Time Frame
Up to approximately 31 months
Description
The safety population included all enrolled 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
Cohort 1 - SCCHN - Treatment Naive
In participants with recurrent or advanced / metastatic squamous cell carcinoma of the head and neck (SSCHN) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg once daily (QD) for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
12
20
13
20
20
20
EG001
Cohort 2 - UC - Treatment Naive
In participants with advanced / metastatic urothelial carcinoma (UC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
12
19
9
19
19
19
EG002
Cohort 3 - RCC - Treatment Naive
In participants with metastatic renal cell carcinoma (RCC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
8
17
8
17
17
17
EG003
Cohort 4 - SCCHN - Previous Treatment Exposure
In participants with SCCHN whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
12
20
10
20
19
20
EG004
Cohort 5 - UC - Previous Treatment Exposure
In participants with UC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
6
7
4
7
7
7
EG005
Cohort 6 - RCC - Previous Treatment Exposure
In participants with RCC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
1
3
1
3
3
3
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG0030 events0 affected20 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected3 at risk
ATRIAL FIBRILLATION
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0021 events1 affected17 at risk
EG003
PERICARDITIS
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
COLITIS
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0012 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0022 events2 affected17 at risk
EG003
DYSPHAGIA
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
ENTEROCOLITIS
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
GASTRITIS EROSIVE
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
ILEUS
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
INTESTINAL OBSTRUCTION
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
LARGE INTESTINAL OBSTRUCTION
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
LARGE INTESTINE PERFORATION
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
PNEUMATOSIS INTESTINALIS
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
RECTAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
UPPER GASTROINTESTINAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
ASTHENIA
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
CHILLS
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
FACE OEDEMA
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
FATIGUE
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
GENERAL PHYSICAL HEALTH DETERIORATION
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
PYREXIA
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
IMMUNE-MEDIATED HEPATITIS
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
DEVICE RELATED SEPSIS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
ENDOCARDITIS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
LOWER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
PHARYNGITIS STREPTOCOCCAL
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected20 at risk
EG0012 events2 affected19 at risk
EG0022 events2 affected17 at risk
EG003
SEPSIS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0013 events2 affected19 at risk
EG0020 events0 affected17 at risk
EG003
HUMERUS FRACTURE
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
INFUSION RELATED REACTION
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
POSTOPERATIVE RESPIRATORY FAILURE
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
ASPARTATE AMINOTRANSFERASE INCREASED
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
EJECTION FRACTION DECREASED
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
TUMOUR HAEMORRHAGE
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
ALTERED STATE OF CONSCIOUSNESS
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
IMMUNE-MEDIATED ENCEPHALITIS
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
DEVICE DISLOCATION
Product Issues
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
NEPHRITIS
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
URINARY RETENTION
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0023 events2 affected17 at risk
EG003
PLEURAL EFFUSION
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
PNEUMONIA ASPIRATION
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
PNEUMONITIS
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
PULMONARY EMBOLISM
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
RESPIRATORY TRACT OEDEMA
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0021 events1 affected17 at risk
EG003
RASH MACULAR
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
RASH MACULO-PAPULAR
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
GASTROSTOMY
Surgical and medical procedures
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
HYPOTENSION
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0009 events8 affected20 at risk
EG0016 events6 affected19 at risk
EG0025 events4 affected17 at risk
EG0034 events2 affected20 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected3 at risk
IRON DEFICIENCY ANAEMIA
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
LEUKOCYTOSIS
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
LEUKOPENIA
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0002 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
LYMPH NODE PAIN
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
LYMPHADENITIS
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
LYMPHOPENIA
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
NEUTROPENIA
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0007 events2 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
THROMBOCYTOPENIA
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
ATRIAL FIBRILLATION
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
ATRIOVENTRICULAR BLOCK FIRST DEGREE
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
CARDIAC FAILURE CONGESTIVE
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
CORONARY ARTERY DISEASE
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
PERICARDITIS
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
SINUS BRADYCARDIA
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
SINUS TACHYCARDIA
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
TACHYCARDIA
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
VENTRICULAR DYSFUNCTION
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
HYPOACUSIS
Ear and labyrinth disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
INNER EAR DISORDER
Ear and labyrinth disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
VERTIGO
Ear and labyrinth disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
HYPERTHYROIDISM
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
HYPOTHYROIDISM
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0004 events3 affected20 at risk
EG0011 events1 affected19 at risk
EG0021 events1 affected17 at risk
EG003
THYROIDITIS
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
CATARACT
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
CHORIORETINOPATHY
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected20 at risk
EG0014 events3 affected19 at risk
EG0022 events2 affected17 at risk
EG003
ENTROPION
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
EYELID OEDEMA
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
EYELID PTOSIS
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
GLAUCOMA
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
LACRIMATION INCREASED
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
MACULAR OEDEMA
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
OPTIC NERVE DISORDER
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
PERIORBITAL OEDEMA
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
RETINAL OEDEMA
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
RETINOPATHY
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
SUBRETINAL FLUID
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
SWELLING OF EYELID
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
TRICHIASIS
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
VISION BLURRED
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
VISUAL IMPAIRMENT
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0011 events1 affected19 at risk
EG0021 events1 affected17 at risk
EG003
VITREOUS FLOATERS
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
ABDOMINAL DISCOMFORT
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
ABDOMINAL DISTENSION
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0021 events1 affected17 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0013 events2 affected19 at risk
EG0022 events2 affected17 at risk
EG003
ANAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
ANGULAR CHEILITIS
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
ASCITES
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
CHEILITIS
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0017 events5 affected19 at risk
EG0023 events3 affected17 at risk
EG003
DIAPHRAGMATIC HERNIA
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0009 events7 affected20 at risk
EG00115 events11 affected19 at risk
EG00213 events9 affected17 at risk
EG003
DRY MOUTH
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0011 events1 affected19 at risk
EG0021 events1 affected17 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected20 at risk
EG0014 events4 affected19 at risk
EG0023 events3 affected17 at risk
EG003
DYSPHAGIA
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected20 at risk
EG0013 events2 affected19 at risk
EG0021 events1 affected17 at risk
EG003
FLATULENCE
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
GASTRIC ULCER
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
GASTRITIS
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
GASTROOESOPHAGEAL REFLUX DISEASE
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
GINGIVAL BLEEDING
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
GLOSSITIS
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
GLOSSODYNIA
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
HAEMATEMESIS
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
HAEMATOCHEZIA
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events2 affected19 at risk
EG0020 events0 affected17 at risk
EG003
HAEMORRHOIDS
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
LIP OEDEMA
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
LIP PAIN
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
LIP SWELLING
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
MOUTH ULCERATION
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
MUCOUS STOOLS
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0006 events6 affected20 at risk
EG0013 events3 affected19 at risk
EG0025 events5 affected17 at risk
EG003
OESOPHAGITIS
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
ORAL DISCHARGE
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
ORAL PAIN
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
RECTAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
STOMATITIS
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0003 events2 affected20 at risk
EG0015 events5 affected19 at risk
EG0022 events2 affected17 at risk
EG003
TOOTHACHE
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0009 events7 affected20 at risk
EG0018 events4 affected19 at risk
EG0023 events3 affected17 at risk
EG003
ASTHENIA
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0013 events3 affected19 at risk
EG0022 events2 affected17 at risk
EG003
CHEST PAIN
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
CHILLS
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
FACE OEDEMA
General disorders
MedDRA 23.0
Systematic Assessment
EG0003 events2 affected20 at risk
EG0012 events2 affected19 at risk
EG0022 events2 affected17 at risk
EG003
FACIAL PAIN
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
FATIGUE
General disorders
MedDRA 23.0
Systematic Assessment
EG0006 events6 affected20 at risk
EG00114 events9 affected19 at risk
EG0027 events5 affected17 at risk
EG003
GENERALISED OEDEMA
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
INFLUENZA LIKE ILLNESS
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0013 events3 affected19 at risk
EG0020 events0 affected17 at risk
EG003
LOCALISED OEDEMA
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
MALAISE
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
MUCOSAL INFLAMMATION
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0011 events1 affected19 at risk
EG0022 events2 affected17 at risk
EG003
OEDEMA
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0022 events2 affected17 at risk
EG003
OEDEMA PERIPHERAL
General disorders
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected20 at risk
EG0012 events2 affected19 at risk
EG0023 events3 affected17 at risk
EG003
PAIN
General disorders
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected20 at risk
EG0012 events2 affected19 at risk
EG0020 events0 affected17 at risk
EG003
PERIPHERAL SWELLING
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0013 events2 affected19 at risk
EG0020 events0 affected17 at risk
EG003
PYREXIA
General disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected20 at risk
EG0019 events7 affected19 at risk
EG0029 events5 affected17 at risk
EG003
SWELLING FACE
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
HYPERSENSITIVITY
Immune system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
CANDIDA INFECTION
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
CELLULITIS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
CONJUNCTIVITIS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected20 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
CYSTITIS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
CYSTITIS BACTERIAL
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
DEVICE RELATED INFECTION
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
DIVERTICULITIS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
INFECTION
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
LOWER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0004 events3 affected20 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0021 events1 affected17 at risk
EG003
ORAL CANDIDIASIS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
ORAL HERPES
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
OTITIS EXTERNA
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
OTITIS MEDIA
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
RASH PUSTULAR
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected20 at risk
EG0012 events2 affected19 at risk
EG0020 events0 affected17 at risk
EG003
RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
RHINITIS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
SKIN INFECTION
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
STAPHYLOCOCCAL INFECTION
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
TONGUE FUNGAL INFECTION
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
TOOTH INFECTION
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0004 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0022 events2 affected17 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0015 events4 affected19 at risk
EG0022 events2 affected17 at risk
EG003
URINARY TRACT INFECTION STAPHYLOCOCCAL
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
VIRAL INFECTION
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
CONTUSION
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
FACE INJURY
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
INFUSION RELATED REACTION
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0014 events3 affected19 at risk
EG0021 events1 affected17 at risk
EG003
INJURY
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
LIMB INJURY
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
POST PROCEDURAL SWELLING
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
SKIN LACERATION
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
STRESS FRACTURE
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
WOUND COMPLICATION
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events2 affected19 at risk
EG0021 events1 affected17 at risk
EG003
ASPARTATE AMINOTRANSFERASE INCREASED
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0013 events3 affected19 at risk
EG0020 events0 affected17 at risk
EG003
BLOOD ALKALINE PHOSPHATASE INCREASED
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
BLOOD BILIRUBIN INCREASED
Investigations
MedDRA 23.0
Systematic Assessment
EG0002 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
BLOOD CREATINE PHOSPHOKINASE INCREASED
Investigations
MedDRA 23.0
Systematic Assessment
EG0004 events4 affected20 at risk
EG0019 events7 affected19 at risk
EG0023 events3 affected17 at risk
EG003
BLOOD CREATININE INCREASED
Investigations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0014 events4 affected19 at risk
EG0020 events0 affected17 at risk
EG003
BLOOD MAGNESIUM DECREASED
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
BLOOD POTASSIUM DECREASED
Investigations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
BLOOD PRESSURE DECREASED
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
BLOOD PRESSURE INCREASED
Investigations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
BLOOD THYROID STIMULATING HORMONE INCREASED
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
BLOOD URIC ACID INCREASED
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
BRAIN NATRIURETIC PEPTIDE INCREASED
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
C-REACTIVE PROTEIN INCREASED
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
CYTOMEGALOVIRUS TEST POSITIVE
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
EJECTION FRACTION DECREASED
Investigations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0023 events2 affected17 at risk
EG003
GAMMA-GLUTAMYLTRANSFERASE INCREASED
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
HAEMOGLOBIN DECREASED
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
INTERNATIONAL NORMALISED RATIO INCREASED
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
PLATELET COUNT DECREASED
Investigations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
PLATELET COUNT INCREASED
Investigations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
VITAMIN B12 DECREASED
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
VITAMIN D DECREASED
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
WEIGHT DECREASED
Investigations
MedDRA 23.0
Systematic Assessment
EG0003 events2 affected20 at risk
EG0013 events3 affected19 at risk
EG0021 events1 affected17 at risk
EG003
CACHEXIA
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
DECREASED APPETITE
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0004 events4 affected20 at risk
EG0018 events7 affected19 at risk
EG0024 events3 affected17 at risk
EG003
DEHYDRATION
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected20 at risk
EG0010 events0 affected19 at risk
EG0022 events1 affected17 at risk
EG003
HYPERCALCAEMIA
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
HYPERGLYCAEMIA
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
HYPERKALAEMIA
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
HYPOALBUMINAEMIA
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0014 events3 affected19 at risk
EG0027 events6 affected17 at risk
EG003
HYPOCALCAEMIA
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
HYPOKALAEMIA
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0003 events2 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
HYPOMAGNESAEMIA
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0002 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
HYPONATRAEMIA
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0013 events3 affected19 at risk
EG0021 events1 affected17 at risk
EG003
HYPOPHOSPHATAEMIA
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0012 events2 affected19 at risk
EG0020 events0 affected17 at risk
EG003
IRON DEFICIENCY
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected20 at risk
EG0013 events2 affected19 at risk
EG0023 events3 affected17 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0021 events1 affected17 at risk
EG003
BONE PAIN
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
FLANK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
GROIN PAIN
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0021 events1 affected17 at risk
EG003
JOINT SWELLING
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0003 events2 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
MUSCLE SPASMS
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
MUSCULAR WEAKNESS
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
MUSCULOSKELETAL CHEST PAIN
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
MUSCULOSKELETAL PAIN
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events2 affected19 at risk
EG0021 events1 affected17 at risk
EG003
MYOSITIS
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
NECK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
OSTEONECROSIS OF JAW
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected20 at risk
EG0012 events2 affected19 at risk
EG0021 events1 affected17 at risk
EG003
SYNOVITIS
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
TRISMUS
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
ADENOCARCINOMA OF COLON
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
CANCER PAIN
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
KERATOACANTHOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
TUMOUR HAEMORRHAGE
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
APHASIA
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
CAUDA EQUINA SYNDROME
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
CEREBRAL INFARCTION
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0014 events4 affected19 at risk
EG0022 events2 affected17 at risk
EG003
DIZZINESS POSTURAL
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
DYSARTHRIA
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
DYSGEUSIA
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
LETHARGY
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
LUMBAR RADICULOPATHY
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
NEUROPATHY PERIPHERAL
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
PARAESTHESIA
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
PRESYNCOPE
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events2 affected19 at risk
EG0020 events0 affected17 at risk
EG003
RESTLESS LEGS SYNDROME
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
SCIATICA
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
STATUS EPILEPTICUS
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
SYNCOPE
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
TASTE DISORDER
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
ANGER
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
ANXIETY
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
CONFUSIONAL STATE
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected20 at risk
EG0011 events1 affected19 at risk
EG0021 events1 affected17 at risk
EG003
DEPRESSION
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
DISORIENTATION
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
INSOMNIA
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
ACUTE KIDNEY INJURY
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0021 events1 affected17 at risk
EG003
DYSURIA
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events2 affected19 at risk
EG0020 events0 affected17 at risk
EG003
HAEMATURIA
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0014 events3 affected19 at risk
EG0020 events0 affected17 at risk
EG003
NOCTURIA
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
POLLAKIURIA
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
PROTEINURIA
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
RENAL FAILURE
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
RENAL IMPAIRMENT
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
URINARY RETENTION
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
URINARY TRACT OBSTRUCTION
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
URINARY TRACT PAIN
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
SCROTAL OEDEMA
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
TESTICULAR SWELLING
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
VAGINAL DISCHARGE
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
VAGINAL HAEMORRHAGE
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events2 affected19 at risk
EG0020 events0 affected17 at risk
EG003
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0015 events4 affected19 at risk
EG0022 events2 affected17 at risk
EG003
DYSPHONIA
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0014 events4 affected19 at risk
EG0021 events1 affected17 at risk
EG003
DYSPNOEA EXERTIONAL
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
EPISTAXIS
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
HAEMOPTYSIS
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
LARYNGEAL OEDEMA
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
NASAL CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
NASAL OBSTRUCTION
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
PNEUMONITIS
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected20 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
PRODUCTIVE COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
RALES
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
WHEEZING
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
ALOPECIA
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
BLISTER
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
DERMATITIS
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected20 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
DERMATITIS ACNEIFORM
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events2 affected19 at risk
EG0023 events3 affected17 at risk
EG003
DERMATITIS PSORIASIFORM
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
DRY SKIN
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected20 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
ECZEMA
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
ERYTHEMA
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
INTERTRIGO
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
NIGHT SWEATS
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
ONYCHOCLASIS
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
PRURITUS
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected20 at risk
EG0013 events3 affected19 at risk
EG0022 events1 affected17 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG00010 events9 affected20 at risk
EG00111 events9 affected19 at risk
EG00214 events12 affected17 at risk
EG003
RASH ERYTHEMATOUS
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
RASH MACULO-PAPULAR
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
RASH PAPULAR
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
RASH PRURITIC
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
SKIN FISSURES
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0012 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
STASIS DERMATITIS
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
URTICARIA
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0023 events1 affected17 at risk
EG003
FLUSHING
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
HYPOTENSION
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0022 events2 affected17 at risk
EG003
LYMPHOEDEMA
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected20 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
ORTHOSTATIC HYPOTENSION
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events1 affected19 at risk
EG0020 events0 affected17 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
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
In participants with metastatic renal cell carcinoma (RCC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
OG003
Cohort 4 - SCCHN - Previous Treatment Exposure
In participants with SCCHN whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
OG004
Cohort 5 - UC - Previous Treatment Exposure
In participants with UC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
OG005
Cohort 6 - RCC - Previous Treatment Exposure
In participants with RCC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
Units
Counts
Participants
OG00020
OG00120
OG00217
OG00320
OG0047
OG0053
Title
Denominators
Categories
Title
Measurements
OG00016.8(6.9 to 25.8)
OG00118.7(11.0 to 26.2)
OG00221.7(17.4 to NA)NA=not estimable
OG0037.7(4.0 to NA)NA=not estimable
OG0045.9(3.1 to 12.5)
OG005NA(5.9 to NA)NA=not estimable
OG002
Cohort 3 - RCC - Treatment Naive
In participants with metastatic renal cell carcinoma (RCC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
OG003
Cohort 4 - SCCHN - Previous Treatment Exposure
In participants with SCCHN whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
OG004
Cohort 5 - UC - Previous Treatment Exposure
In participants with UC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
OG005
Cohort 6 - RCC - Previous Treatment Exposure
In participants with RCC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
Units
Counts
Participants
OG00020
OG00120
OG00217
OG00320
OG0047
OG0053
Title
Denominators
Categories
Title
Measurements
OG0005.5(2 to 26)
OG0013.4(2 to 26)
OG0023.4(1 to 28)
OG0033.6(0 to 9)
OG0042.1(1 to 4)
OG0052.7(1 to 4)
OG001
Cohort 2 - UC - Treatment Naive
In participants with advanced / metastatic urothelial carcinoma (UC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
OG002
Cohort 3 - RCC - Treatment Naive
In participants with metastatic renal cell carcinoma (RCC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
OG003
Cohort 4 - SCCHN - Previous Treatment Exposure
In participants with SCCHN whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
OG004
Cohort 5 - UC - Previous Treatment Exposure
In participants with UC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
OG005
Cohort 6 - RCC - Previous Treatment Exposure
In participants with RCC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
Units
Counts
Participants
OG00020
OG00120
OG00217
OG0030
OG0040
OG0050
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)NA=not estimable: Kaplan-Meier was not estimable because there were too few events in Cohort 1.
OG001149.0(125.0 to 173.0)
OG002NA(NA to NA)NA=not estimable: Kaplan-Meier was not estimable because there were too few events in Cohort 3.
OG002
Cohort 3 - RCC - Treatment Naive
In participants with metastatic renal cell carcinoma (RCC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
OG003
Cohort 4 - SCCHN - Previous Treatment Exposure
In participants with SCCHN whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
OG004
Cohort 5 - UC - Previous Treatment Exposure
In participants with UC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
OG005
Cohort 6 - RCC - Previous Treatment Exposure
In participants with RCC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
Units
Counts
Participants
OG00020
OG00120
OG00217
OG00320
OG0047
OG0053
Title
Denominators
Categories
Title
Measurements
OG00050.0(25.59 to 74.41)
OG00140.0(16.03 to 63.97)
OG00223.5(0.42 to 46.63)
OG00325.0(3.52 to 46.48)
OG0040(0.00 to 7.14)
OG0050(0.00 to 16.67)
OG002
Cohort 3 - RCC - Treatment Naive
In participants with metastatic renal cell carcinoma (RCC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
OG003
Cohort 4 - SCCHN - Previous Treatment Exposure
In participants with SCCHN whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
OG004
Cohort 5 - UC - Previous Treatment Exposure
In participants with UC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
OG005
Cohort 6 - RCC - Previous Treatment Exposure
In participants with RCC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
Units
Counts
Participants
OG00020
OG00119
OG00217
OG00320
OG0047
OG0053
Title
Denominators
Categories
Title
Measurements
OG00020
OG00119
OG00217
OG00320
OG0047
OG0053
33
Title
Denominators
Categories
Title
Measurements
OG000285± 56.5
30
Title
Denominators
Categories
Title
Measurements
OG000174± 152
40
Title
Denominators
Categories
Title
Measurements
OG000417000± 50.2
61
Title
Denominators
Categories
Title
Measurements
OG000112000± 219
OG001
Cohort 2 - UC - Treatment Naive
In participants with advanced / metastatic urothelial carcinoma (UC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
OG002
Cohort 3 - RCC - Treatment Naive
In participants with metastatic renal cell carcinoma (RCC) who were anti-PD-1 and anti-PD-L1 treatment naive, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
OG003
Cohort 4 - SCCHN - Previous Treatment Exposure
In participants with SCCHN whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
OG004
Cohort 5 - UC - Previous Treatment Exposure
In participants with UC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.
OG005
Cohort 6 - RCC - Previous Treatment Exposure
In participants with RCC whose disease had progressed while receiving anti-PD-1 or anti-PD-L1 therapy, cobimetinib was administered at the approved dose and schedule of 60 mg QD for 21 days and 7 days off of each 28-day cycle; and atezolizumab 840 mg by IV infusion on Days 1 and 15 of each 28-day cycle.