A Study Of Multiple Immunotherapy-Based Treatment Combina... | NCT03337698 | Trialant
NCT03337698
Sponsor
Hoffmann-La Roche
Status
Terminated
Last Update Posted
May 12, 2026Actual
Enrollment
314Actual
Phase
Phase 1Phase 2
Conditions
Carcinoma, Non-Small-Cell Lung
Interventions
Atezolizumab
Cobimetinib
RO6958688
Docetaxel
CPI-444
Pemetrexed
Carboplatin
Gemcitabine
Linagliptin
Tocilizumab
Ipatasertib
Bevacizumab
Sacituzumab Govitecan
Radiation
Evolocumab
Tiragolumab
XL092
Camonsertib
Countries
United States
Australia
France
Israel
South Korea
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03337698
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
BO39610
Secondary IDs
ID
Type
Description
Link
2017-001267-21
EudraCT Number
Brief Title
A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer)
Official Title
A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations In Patients With Metastatic Non-Small Cell Lung Cancer (Morpheus-Lung)
Acronym
Morpheus Lung
Organization
Hoffmann-La RocheINDUSTRY
Status Module
Record Verification Date
Apr 2026
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Study was closed early as the sponsor decided not to continue development of certain treatment combinations.
Expanded Access Info
No
Start Date
Dec 27, 2017Actual
Primary Completion Date
Oct 14, 2025Actual
Completion Date
Nov 25, 2025Actual
First Submitted Date
Nov 7, 2017
First Submission Date that Met QC Criteria
Nov 7, 2017
First Posted Date
Nov 9, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Mar 23, 2026
Results First Submitted that Met QC Criteria
Apr 20, 2026
Results First Posted Date
May 12, 2026Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 20, 2026
Last Update Posted Date
May 12, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Hoffmann-La RocheINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study will evaluate the efficacy, safety, and pharmacokinetics of immunotherapy-based treatment combinations in participants with metastatic non-small cell lung cancer (NSCLC).
Two cohorts will be enrolled in parallel in this study: Cohort 1 will consist of participants with tumor PD-L1 expression who have received no prior systemic therapy for metastatic NSCLC, and Cohort 2 will consist of participants who experienced disease progression during or following treatment with a platinum-containing regimen and a PD-L1/PD-1 checkpoint inhibitor, given in combination as one line of therapy or as two separate lines of therapy, regardless of PD-L1 expression. In each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). Participants who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment regimen (Stage 2).
Detailed Description
Not provided
Conditions Module
Conditions
Carcinoma, Non-Small-Cell Lung
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 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
314Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Stage 1: Cohort 1: Atezolizumab
Active Comparator
Participants in the Atezolizumab arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.
Participants who progressed on treatment, may have the option of receiving Atezolizumab + Pemetrexed + Carboplatin or Atezolizumab + Gemcitabine + Carboplatin treatment, provided they meet the eligibility criteria.
Drug: Atezolizumab
Stage 1: Cohort 1: Atezolizumab + Cobimetinib
Experimental
Participants in the Atezolizumab + Cobimetinib arm will receive treatment (cycle length 28 days) until unacceptable toxicity or loss of clinical benefit.
Participants who progressed on 1L treatment, may have the option of receiving Atezolizumab + Pemetrexed + Carboplatin or Atezolizumab + Gemcitabine + Carboplatin treatment, provided they meet the eligibility criteria.
Participants who progressed on 2L/3L treatment, may have the option of receiving Atezolizumab + RO6958688, Atezolizumab + Docetaxel or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.
Drug: Atezolizumab
Drug: Cobimetinib
Stage 1: Cohort 1: Atezolizumab + RO6958688
Experimental
Participants in the Atezolizumab + RO6958688 arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.
Participants who progressed on 1L treatment, may have the option of receiving Atezolizumab + Pemetrexed + Carboplatin or Atezolizumab + Gemcitabine + Carboplatin treatment, provided they meet the eligibility criteria.
Participants who progressed on 2L/3L treatment, may have the option of receiving Atezolizumab + Docetaxel treatment or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Atezolizumab
Drug
Atezolizumab is administered by IV on Day 1 of each 21 day cycle or on Days 1 and 15 of each 28 day cycle.
Stage 1: Cohort 1: Atezolizumab
Stage 1: Cohort 1: Atezolizumab + Cobimetinib
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Stage 1: Percentage of Participants With Objective Response (OR) as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1)
OR was defined as a complete response (CR) or partial response (PR) on two consecutive occasions, ≥4 weeks apart, during Stage 1 as determined by the investigator using RECIST v.1.1. Objective response rate (ORR) was defined as the percentage of participants with OR. CR was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD, in the absence of CR. 95% confidence intervals (CI) for rates were constructed using Clopper-Pearson method. Percentages have been rounded off. The participant in the 'Stage 1 Cohort 2 (S1C2): Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the efficacy analyses.
Up to 50.4 months
Secondary Outcomes
Measure
Description
Time Frame
Stage 1: Progression-free Survival (PFS) as Determined by Investigator According to RECIST V1.1
PFS was defined as the time from study treatment initiation to the first occurrence of documented PD, as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or unequivocal progression of existing non-target lesions. Participants who did not have documented PD or death, PFS was censored at the day of the last tumor assessment. Kaplan-Meier (K-M) method was used to estimate PFS. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the efficacy analyses.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
General Inclusion Criteria
Eastern Cooperative Oncology Group (ECOG) performance Status of 0 or 1
Life expectancy greater than or equal to 3 months
Histologically or cytologically confirmed metastatic, non-squamous or squamous Non-Small Cell Lung Cancer (NSCLC)
Measurable disease (at least one target lesion)
Adequate hematologic and end-organ function
Tumor accessible for biopsy
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating eggs as outlined for each specific treatment arm
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as outlined for each specific treatment arm
Inclusion Criteria for Cohort 1
No prior systemic therapy for metastatic NSCLC
High tumor PD-L1 expression, defined as Tumor Proportion Score (TPS) or TCs >= 50% or TC3
Inclusion Criteria for Cohort 2
- Disease progression during or following treatment for metastatic or locally advanced, inoperable NSCLC
Exclusion Criteria
Prior allogeneic stem cell or solid organ transplantation
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
History of leptomeningeal disease
Active or history of autoimmune disease or immune deficiency
History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan
History of malignancy other than NSCLC within 2 years prior to screening
Active tuberculosis
Severe infection within 4 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
Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
Las Vegas
Nevada
89169
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Eligible participants were assigned to 1 of several treatment arms in Stage 1. Participants with PD, loss of clinical benefit, or unacceptable toxicity in Stage 1 were eligible for a different treatment combination in Stage 2. Participants in Stage 1 who did not enter Stage 2 & those who completed Stage 2 treatment entered the long-term survival follow-up. Results include only those cohorts that enrolled participants; planned cohorts that were never opened for enrollment are not presented.
Recruitment Details
A total of 314 participants with metastatic non-small cell lung cancer (NSCLC) took part in the study from 27 Dec 2017 to 25 Nov 2025. The study had 2 cohorts: Cohort 1: participants with no prior systemic therapy for metastatic NSCLC & Cohort 2: participants with 1 prior line of systemic therapy for NSCLC. Multiple combination therapies were compared against common control(s) in Cohorts 1 and 2.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Stage 1 Cohort 1: Control (Atezolizumab)
Participants received atezolizumab 1200 milligrams (mg), intravenous (IV) infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
FG001
Periods
Title
Milestones
Reasons Not Completed
Stage 1
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
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)
Yes
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Dec 1, 2023
Mar 23, 2026
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Taiwan
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: Atezolizumab
Drug: RO6958688
Drug: Tocilizumab
Stage 1: Cohort 2: Docetaxel
Active Comparator
Participants in the Docetaxel arm will receive treatment (cycle length 21 days) until unacceptable toxicity or disease progression.
Participants who progressed on treatment may have the option of receiving Atezolizumab + RO6958688 or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.
Drug: Docetaxel
Stage 1: Cohort 2: Atezolizumab + Cobimetinib
Experimental
Participants in the Atezolizumab + Cobimetinib arm will receive treatment (cycle length 28 days) until unacceptable toxicity or loss of clinical benefit.
Participants who progressed on treatment, may have the option of receiving Atezolizumab + Pemetrexed + Carboplatin, Atezolizumab + Gemcitabine + Carboplatin, Atezolizumab + RO6958688, Atezolizumab + Docetaxel or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.
Drug: Atezolizumab
Drug: Cobimetinib
Stage 1: Cohort 2: Atezolizumab + CPI-444
Experimental
Participants in the Atezolizumab + CPI-444 arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.
Participants who progressed on treatment, may have the option of receiving Atezolizumab + RO6958688, Atezolizumab + Docetaxel or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.
Drug: Atezolizumab
Drug: CPI-444
Stage 1: Cohort 2: Atezolizumab + RO6958688
Experimental
Participants in the Atezolizumab + RO6958688 arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.
Participants who progressed on treatment, may have the option of receiving Atezolizumab + Pemetrexed + Carboplatin, Atezolizumab + Gemcitabine + Carboplatin, Atezolizumab + Docetaxel or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.
Drug: Atezolizumab
Drug: RO6958688
Drug: Tocilizumab
Stage 1: Cohort 2: Atezolizumab + Ipatasertib
Experimental
Participants in the Atezolizumab + Ipatasertib arm will receive treatment (cycle length 28 days) until unacceptable toxicity or loss of clinical benefit.
Participants who progressed on treatment, may have the option of receiving Atezolizumab + Docetaxel treatment or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.
Drug: Atezolizumab
Drug: Ipatasertib
Stage 1: Cohort 2: Atezolizumab + Docetaxel
Experimental
Participants in Atezolizumab + Docetaxel arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.
Participants who progressed on treatment, may have the option of receiving Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.
Drug: Atezolizumab
Drug: Docetaxel
Stage 1: Cohort 2: Atezolizumab + Bevacizumab
Experimental
Participants in Atezolizumab + Bevacizumab arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.
Participants who progressed on treatment, may have the option of receiving Atezolizumab + Docetaxel or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.
Participants in the Atezolizumab + Pemetrexed + Carboplatin arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.
Participants in the Atezolizumab + Gemcitabine + Carboplatin arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.
Drug: Atezolizumab
Drug: Carboplatin
Drug: Gemcitabine
Stage 2: Cohort 2: Atezolizumab + RO6958688
Experimental
Participants in the Atezolizumab + RO6958688 arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.
Drug: Atezolizumab
Drug: RO6958688
Drug: Tocilizumab
Stage 2: Cohort 2: Atezolizumab + Docetaxel
Experimental
Participants in the Atezolizumab + Docetaxel arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.
Participants who have received treatment with Atezolizumab + Docetaxel in Stage 1 will not receive this treatment in Stage 2.
Drug: Atezolizumab
Drug: Docetaxel
Stage 2: Cohort 2: Atezolizumab + Linagliptin
Experimental
Participants in the Atezolizumab + Linagliptin arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.
Participants in the Atezolizumab + Sacituzumab Govitecan arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.
Participants in the Atezolizumab + Bevacizumab + Radioatherapy arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.
Drug: Atezolizumab
Drug: Bevacizumab
Other: Radiation
Stage 1: Cohort 2: Atezolizumab + Evolocumab
Experimental
Participants in the Atezolizumab + Evolocumab arm will receive treatment (cycle length 28 days) until unacceptable toxicity or loss of clinical benefit.
Drug: Atezolizumab
Drug: Evolocumab
Stage 1: Cohort 1: Atezolizumab + Tiragolumab
Active Comparator
Participants in the Atezolizumab + Tiragolumab arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.
Participants in the Atezolizumab + Tiragolumab + XL092 arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.
Drug: Atezolizumab
Drug: Tiragolumab
Drug: XL092
Stage 1: Cohort 2: Atezolizumab + Camonsertib
Experimental
Participants in the Atezolizumab + Camonsertib arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.
Participants in the Atezolizumab + Bevacizumab + Comonsertib arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.
Participants in the Atezolizumab + Bevacizumab + Tiragolumab arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.
From randomization to the first occurrence of PD or death (Up to 48.6 months)
Stage 1: PFS Rate at Month 6
PFS was defined as the time from study treatment initiation to the first occurrence of documented PD, as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or unequivocal progression of existing non-target lesions. Participants who did not have documented PD or death, PFS was censored at the day of the last tumor assessment. The KM approach was used to estimate the percentage of participants who were event-free for PFS at Month 6. Percentages have been rounded off. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the efficacy analyses.
At Month 6
Stage 1: Overall Survival (OS)
OS was defined as the time from randomization to death from any cause. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. K-M method was used to estimate OS. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the efficacy analyses.
From randomization to death (Up to 67 months)
Stage 1: OS Rate at Month 6
OS was defined as the time from randomization to death from any cause. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. The Kaplan-Meier approach was used to estimate the percentage of participants who were event-free for OS at Month 6. Percentages have been rounded off. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the efficacy analyses.
At Month 6
Stage 1: Duration of Response (DOR), as Determined by Investigator According to RECIST V1.1
DOR was defined as the time from the first occurrence of a documented OR until the time of documented PD or death from any cause, whichever occurred first as per investigator assessment using RECIST v1.1. DOR was calculated for participants who had a best confirmed OR of CR/PR. CR and PR were defined as outlined in the description for ORR outcome measure. PD=at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or unequivocal progression of existing non-target lesions. Participants who did not have documented PD or death, DOR was censored at the day of the last tumor assessment. K-M method was used to estimate DOR. The participant in the 'S1C2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the efficacy analyses.
From first occurrence of a documented OR until the time of documented PD or death (Up to 50.4 months)
Stage 1: Percentage of Participants With Disease Control (DC), as Determined by Investigator According to RECIST V1.1
DC was defined as stable disease (SD) for ≥ 12 weeks or a CR or PR, as determined by the investigator according to RECIST v1.1 Disease control rate (DCR) was defined as the percentage of participants with DC. CR was defined as the disappearance of all target & non-target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD=at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or unequivocal progression of existing non-target lesions. Percentages have been rounded off.
Up to 50.4 months
Stages 1 and 2: Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. SAEs = Serious AEs; AESIs = Adverse Events of Special Interest.
From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months)
Institut Universitaire du Cancer de Toulouse-Oncopole
Toulouse
31100
France
Rambam Medical Center
Haifa
3109601
Israel
Rabin Medical Center
Petah Tikva
4941492
Israel
Chaim Sheba Medical Center
Ramat Gan
52620-00
Israel
Seoul National University Hospital
Seoul
03080
South Korea
Severance Hospital, Yonsei University Health System
Seoul
03722
South Korea
Korea University Guro Hospital
Seoul
08308
South Korea
University of Ulsan College of Medicine - Asan Medical Center (AMC) - Asan Cancer Center (ACC)
Songpa-gu
05505
South Korea
ClÃnica Universidad de Navarra
Pamplona
Navarre
31008
Spain
Hospital Universitari Vall d'Hebron
Barcelona
08035
Spain
Hospital Universitario La Paz
Madrid
280146
Spain
Fundación Jimenez DÃaz
Madrid
28040
Spain
Hospital Universitario HM Sanchinarro-CIOCC
Madrid
28050
Spain
Hospital Regional Universitario de Malaga
Málaga
29010
Spain
Hospital Clinico Universitario de Valencia
Valencia
46010
Spain
Barts Cancer Institute
London
E1 2AT
United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne
NE1 4LP
United Kingdom
Royal Marsden Hospital
Sutton
SM2 5PT
United Kingdom
Stage 1 Cohort 1: Atezolizumab + Cobimetinib
Participants received cobimetinib 60 mg, orally (PO), once daily (QD) on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Participants received atezolizumab 1200 mg, IV on Day 1 and carcinoembryonic antigen - T-cell bispecific antibody [CEA-TCB] 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab, 1200 mg, IV on Day 1 and CEA-TCB, 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
FG003
Stage 1 Cohort 1: Atezolizumab + Tiragolumab
Participants received atezolizumab 1200 mg and tiragolumab 600 mg, IV infusions on Day 1 of each cycle until disease progression (PD), loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up. Cohort 1 was reactivated with 'Atezo + Tira' as a new comparator arm.
FG004
Stage 1 Cohort 2: Control (Docetaxel)
Participants received docetaxel 75 milligrams per square meter (mg/m^2), IV over 60 minutes on Day 1 of each cycle until PD or unacceptable toxicity (cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
FG005
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
FG006
Stage 1 Cohort 2: Atezolizumab + CEA-TCB
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
FG007
Stage 1 Cohort 2: Atezolizumab + CPI-444
Participants received CPI-444 100 mg, PO, twice daily (BID), on Days 1-21 and atezolizumab, 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
FG008
Stage 1 Cohort 2: Docetaxel + Atezolizumab
Participants received docetaxel 75 mg/m^2 IV over 60 minutes and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
FG009
Stage 1 Cohort 2: Atezolizumab + Ipatasertib
Participants received ipatasertib 400 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
FG010
Stage 1 Cohort 2: Idasanutlin + Docetaxel
Participants received idasanutlin 150 mg, PO, QD on Days 1-5 of each cycle and docetaxel 50 mg/m^2, IV infusion on Days 1 and 15 of each cycle until PD or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
FG011
Stage 1 Cohort 2: Atezolizumab + Bevacizumab
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 milligrams per kilogram (mg/kg), IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). Participants also received stereotactic radiotherapy as outlined in the technical radiotherapy manual up to 21 days. After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Participants received sacituzumab govitecan 10 mg/kg, IV infusion on Days 1 and 8 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
FG014
Stage 1 Cohort 2: Atezolizumab + Evolocumab
Participants received evolocumab 140 mg, SC injection, and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
FG015
Stage 1 Cohort 2: Atezolizumab + Camonsertib
Participants received camonsertib 160 mg, PO on Days 1-3 and Days 8-10 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Participants received atezolizumab 1200 mg, IV infusions on Day 1 of each cycle, pemetrexed, 500 mg/m^2, IV infusions on Day 1 of each cycle and carboplatin area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) (Calvert formula dosing), IV infusion on Day 1 of the first four or six cycles, until PD, loss of clinical benefit or unacceptable toxicity (cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
FG017
Stage 2 Cohort 2: Docetaxel + Atezolizumab
Participants received atezolizumab 1200 mg, IV infusions, and docetaxel 75 mg/m^2, IV infusion over 1 hour on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
FG018
Stage 2 Cohort 2: Atezolizumab + Linagliptin
Participants received linagliptin 5 mg, PO, QD on Days 1-21 and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
FG0003 subjects
FG0015 subjects
FG0021 subjects
FG0031 subjects
FG00466 subjects
FG00515 subjects
FG0061 subjects
FG00716 subjects
FG00818 subjects
FG00931 subjects
FG0101 subjects
FG01141 subjects
FG01245 subjects
FG01330 subjects
FG01432 subjects
FG0158 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
Safety-evaluable Population
Safety-evaluable population included all participants who received any amount of study treatment.
FG0003 subjects
FG0015 subjects
FG0021 subjects
FG0031 subjects
FG00461 subjects
FG00515 subjects
FG0061 subjects
FG00715 subjects
FG00816 subjects
FG00930 subjects
FG0100 subjects
FG01140 subjects
FG01243 subjects
FG01330 subjects
FG01431 subjects
FG0158 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
COMPLETED
FG0001 subjects
FG0015 subjects
FG0021 subjects
FG0031 subjects
FG00452 subjects
FG00510 subjects
FG0061 subjects
FG00712 subjects
FG00813 subjects
FG00929 subjects
FG0100 subjects
FG01137 subjects
FG01234 subjects
FG01328 subjects
FG01431 subjects
FG0157 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
NOT COMPLETED
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00414 subjects
FG0055 subjects
FG0060 subjects
FG0074 subjects
FG0085 subjects
FG0092 subjects
FG0101 subjects
FG0114 subjects
FG01211 subjects
FG0132 subjects
FG0141 subjects
FG0151 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
Type
Comment
Reasons
Death
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0044 subjects
FG0052 subjects
FG0060 subjects
FG0073 subjects
FG0082 subjects
FG0090 subjects
FG0100 subjects
FG0113 subjects
FG0124 subjects
FG0131 subjects
FG0140 subjects
FG0151 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Progressive Disease
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Study Terminated by Sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Stage 2
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0162 subjects
FG01733 subjects
FG01822 subjects
Safety-evaluable Population
Safety-evaluable population included all participants who received any amount of study treatment.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Study Terminated by Sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Long-term Survival Follow-up
Type
Comment
Milestone Data
STARTED
FG0001 subjects
FG0014 subjects
FG0020 subjects
FG0031 subjects
FG00436 subjects
FG0059 subjects
FG0061 subjects
FG0079 subjects
FG00811 subjects
FG00920 subjects
FG0100 subjects
FG01126 subjects
FG01228 subjects
FG01320 subjects
FG01430 subjects
FG0155 subjects
FG0162 subjects
FG01728 subjects
FG01819 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0001 subjects
FG0014 subjects
FG0020 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
Arm Terminated by Sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Randomized population included all participants randomized to each treatment arm.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Stage 1 Cohort 1: Control (Atezolizumab)
Participants received atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
BG001
Stage 1 Cohort 1: Atezolizumab + Cobimetinib
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
BG002
Stage 1 Cohort 1: Atezolizumab + CEA-TCB
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab, 1200 mg, IV on Day 1 and CEA-TCB, 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
BG003
Stage 1 Cohort 1: Atezolizumab + Tiragolumab
Participants received atezolizumab 1200 mg and tiragolumab 600 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up. Cohort 1 was reactivated with 'Atezo + Tira' as a new comparator arm.
BG004
Stage 1 Cohort 2: Control (Docetaxel)
Participants received docetaxel 75 mg/m^2, IV over 60 minutes on Day 1 of each cycle until PD or unacceptable toxicity (cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
BG005
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
BG006
Stage 1 Cohort 2: Atezolizumab + CEA-TCB
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
BG007
Stage 1 Cohort 2: Atezolizumab + CPI-444
Participants received CPI-444 100 mg, PO, BID, on Days 1-21 and atezolizumab, 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
BG008
Stage 1 Cohort 2: Docetaxel + Atezolizumab
Participants received docetaxel 75 mg/m^2 IV over 60 minutes and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
BG009
Stage 1 Cohort 2: Atezolizumab + Ipatasertib
Participants received ipatasertib 400 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
BG010
Stage 1 Cohort 2: Idasanutlin + Docetaxel
Participants received idasanutlin 150 mg, PO, QD on Days 1-5 of each cycle and docetaxel 50 mg/m^2, IV infusion on Days 1 and 15 of each cycle until PD or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
BG011
Stage 1 Cohort 2: Atezolizumab + Bevacizumab
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). Participants also received stereotactic radiotherapy as outlined in the technical radiotherapy manual up to 21 days. After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
BG013
Stage 1 Cohort 2: Atezolizumab + SG
Participants received sacituzumab govitecan 10 mg/kg, IV infusion on Days 1 and 8 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
BG014
Stage 1 Cohort 2: Atezolizumab + Evolocumab
Participants received evolocumab 140 mg, SC injection, and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
BG015
Stage 1 Cohort 2: Atezolizumab + Camonsertib
Participants received camonsertib 160 mg, PO on Days 1-3 and Days 8-10 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Participants received atezolizumab 1200 mg, IV infusions on Day 1 of each cycle, pemetrexed, 500 mg/m^2, IV infusions on Day 1 of each cycle and carboplatin AUC 6 mg/mL/min (Calvert formula dosing), IV infusion on Day 1 of the first four or six cycles, until PD, loss of clinical benefit or unacceptable toxicity (cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
BG017
Stage 2 Cohort 2: Docetaxel + Atezolizumab
Participants received atezolizumab 1200 mg, IV infusions, and docetaxel 75 mg/m^2, IV infusion over 1 hour on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
BG018
Stage 2 Cohort 2: Atezolizumab + Linagliptin
Participants received linagliptin 5 mg, PO, QD on Days 1-21 and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
BG019
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0015
BG0021
BG0031
BG00466
BG00515
BG0061
BG00716
BG00818
BG00931
BG0101
BG01141
BG01245
BG01330
BG01432
BG0158
BG0162
BG01733
BG01822
BG019371
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
Count of Participants
Participants
Title
Denominators
Categories
Stage 1
ParticipantsBG0003
ParticipantsBG0015
ParticipantsBG0021
ParticipantsBG003
Sex: Female, Male
Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
Count of Participants
Participants
Title
Denominators
Categories
Stage 1
ParticipantsBG0003
ParticipantsBG0015
ParticipantsBG002
Ethnicity (NIH/OMB)
Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
Count of Participants
Participants
Title
Denominators
Categories
Stage 1
ParticipantsBG0003
ParticipantsBG0015
ParticipantsBG002
Race (NIH/OMB)
Number analyzed is the number of participants who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and entered Stage 2 to continue treatment with a different treatment regimen.
Count of Participants
Participants
Title
Denominators
Categories
Stage 1
ParticipantsBG0003
ParticipantsBG0015
ParticipantsBG002
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
Stage 1: Percentage of Participants With Objective Response (OR) as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1)
OR was defined as a complete response (CR) or partial response (PR) on two consecutive occasions, ≥4 weeks apart, during Stage 1 as determined by the investigator using RECIST v.1.1. Objective response rate (ORR) was defined as the percentage of participants with OR. CR was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD, in the absence of CR. 95% confidence intervals (CI) for rates were constructed using Clopper-Pearson method. Percentages have been rounded off. The participant in the 'Stage 1 Cohort 2 (S1C2): Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the efficacy analyses.
Efficacy population included all participants who received at least one dose of each drug for their assigned treatment regimen. Cohort 1 with 'Atezolizumab (control arm)' was closed during the study conduct and was reactivated with 'Atezo + Tira' as a new comparator arm. Comparative statistics are not presented for Atezo + Tira arm & Atezo + CEA-TCB arms (Cohorts 1 & 2) due to the small sample size (N=1), which precludes any meaningful conclusion.
Posted
Number
95% Confidence Interval
percentage of participants
Up to 50.4 months
ID
Title
Description
OG000
Stage 1 Cohort 1: Control (Atezolizumab)
Participants received atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG001
Stage 1 Cohort 1: Atezolizumab + Cobimetinib
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG002
Stage 1 Cohort 1: Atezolizumab + CEA-TCB
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab, 1200 mg, IV on Day 1 and CEA-TCB, 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG003
Stage 1 Cohort 1: Atezolizumab + Tiragolumab
Participants received atezolizumab 1200 mg and tiragolumab 600 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up. Cohort 1 was reactivated with 'Atezo + Tira' as a new comparator arm.
OG004
Stage 1 Cohort 2: Control (Docetaxel)
Participants received docetaxel 75 mg/m^2, IV over 60 minutes on Day 1 of each cycle until PD or unacceptable toxicity (cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Units
Counts
Participants
OG0003
OG0015
OG0021
OG003
Title
Denominators
Categories
Title
Measurements
OG00033.3(0.84 to 90.57)
OG0010(0.00 to 52.18)
OG002100(2.50 to 100.00)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Difference in Overall Response Rates
-33.33
2-Sided
95
-100.00
46.68
Superiority
OG004
OG005
Secondary
Stage 1: Progression-free Survival (PFS) as Determined by Investigator According to RECIST V1.1
PFS was defined as the time from study treatment initiation to the first occurrence of documented PD, as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or unequivocal progression of existing non-target lesions. Participants who did not have documented PD or death, PFS was censored at the day of the last tumor assessment. Kaplan-Meier (K-M) method was used to estimate PFS. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the efficacy analyses.
Efficacy population included all participants who received at least one dose of each drug for their assigned treatment regimen. Cohort 1 with 'Atezolizumab (control arm)' was closed during the study conduct and was reactivated with "Atezo + Tira" as a new comparator arm. Comparative statistics are not presented for Atezo + Tira arm & Atezo + CEA-TCB arms (Cohorts 1 & 2) due to the small sample size (N=1), which precludes any meaningful conclusion.
Posted
Median
95% Confidence Interval
months
From randomization to the first occurrence of PD or death (Up to 48.6 months)
ID
Title
Description
OG000
Stage 1 Cohort 1: Control (Atezolizumab)
Participants received atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Secondary
Stage 1: PFS Rate at Month 6
PFS was defined as the time from study treatment initiation to the first occurrence of documented PD, as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or unequivocal progression of existing non-target lesions. Participants who did not have documented PD or death, PFS was censored at the day of the last tumor assessment. The KM approach was used to estimate the percentage of participants who were event-free for PFS at Month 6. Percentages have been rounded off. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the efficacy analyses.
Efficacy population included all participants who received at least one dose of each drug for their assigned treatment regimen. Cohort 1 with 'Atezolizumab (control arm)' was closed during the study conduct and was reactivated with 'Atezo + Tira' as a new comparator arm. Comparative statistics are not presented for Atezo + Tira arm & Atezo + CEA-TCB arms (Cohorts 1 & 2) due to the small sample size (N=1), which precludes any meaningful conclusion.
Posted
Number
95% Confidence Interval
percentage of participants
At Month 6
ID
Title
Description
OG000
Stage 1 Cohort 1: Control (Atezolizumab)
Participants received atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Secondary
Stage 1: Overall Survival (OS)
OS was defined as the time from randomization to death from any cause. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. K-M method was used to estimate OS. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the efficacy analyses.
Efficacy population included all participants who received at least one dose of each drug for their assigned treatment regimen. Cohort 1 with 'Atezolizumab (control arm)' was closed during the study conduct and was reactivated with 'Atezo + Tira' as a new comparator arm. Comparative statistics are not presented for Atezo + Tira arm & Atezo + CEA-TCB arms (Cohorts 1 & 2) due to the small sample size (N=1), which precludes any meaningful conclusion.
Posted
Median
95% Confidence Interval
months
From randomization to death (Up to 67 months)
ID
Title
Description
OG000
Stage 1 Cohort 1: Control (Atezolizumab)
Participants received atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG001
Stage 1 Cohort 1: Atezolizumab + Cobimetinib
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Secondary
Stage 1: OS Rate at Month 6
OS was defined as the time from randomization to death from any cause. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. The Kaplan-Meier approach was used to estimate the percentage of participants who were event-free for OS at Month 6. Percentages have been rounded off. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the efficacy analyses.
Efficacy population included all participants who received at least one dose of each drug for their assigned treatment regimen. Cohort 1 with 'Atezolizumab (control arm)' was closed during the study conduct and was reactivated with 'Atezo + Tira' as a new comparator arm. Comparative statistics are not presented for Atezo + Tira arm & Atezo + CEA-TCB arms (Cohorts 1 & 2) due to the small sample size (N=1), which precludes any meaningful conclusion.
Posted
Number
95% Confidence Interval
percentage of participants
At Month 6
ID
Title
Description
OG000
Stage 1 Cohort 1: Control (Atezolizumab)
Participants received atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG001
Stage 1 Cohort 1: Atezolizumab + Cobimetinib
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Secondary
Stage 1: Duration of Response (DOR), as Determined by Investigator According to RECIST V1.1
DOR was defined as the time from the first occurrence of a documented OR until the time of documented PD or death from any cause, whichever occurred first as per investigator assessment using RECIST v1.1. DOR was calculated for participants who had a best confirmed OR of CR/PR. CR and PR were defined as outlined in the description for ORR outcome measure. PD=at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or unequivocal progression of existing non-target lesions. Participants who did not have documented PD or death, DOR was censored at the day of the last tumor assessment. K-M method was used to estimate DOR. The participant in the 'S1C2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the efficacy analyses.
Efficacy population=all participants who received at least 1 dose of each drug for their assigned treatment regimen. Overall number analyzed=all participants who achieved OR. Cohort 1 with 'Atezolizumab (control arm)' was closed during the study conduct & was reactivated with 'Atezo + Tira' as a new comparator arm. Comparative statistics are not presented for Atezo + Tira arm & Atezo + CEA-TCB arms (Cohorts 1 & 2) due to the small sample size (N=1), which precludes any meaningful conclusion.
Posted
Median
95% Confidence Interval
months
From first occurrence of a documented OR until the time of documented PD or death (Up to 50.4 months)
ID
Title
Description
OG000
Stage 1 Cohort 1: Control (Atezolizumab)
Secondary
Stage 1: Percentage of Participants With Disease Control (DC), as Determined by Investigator According to RECIST V1.1
DC was defined as stable disease (SD) for ≥ 12 weeks or a CR or PR, as determined by the investigator according to RECIST v1.1 Disease control rate (DCR) was defined as the percentage of participants with DC. CR was defined as the disappearance of all target & non-target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD=at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or unequivocal progression of existing non-target lesions. Percentages have been rounded off.
Efficacy population included all participants who received at least one dose of each drug for their assigned treatment regimen. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the efficacy analyses.
Posted
Number
95% Confidence Interval
percentage of participants
Up to 50.4 months
ID
Title
Description
OG000
Stage 1 Cohort 1: Control (Atezolizumab)
Participants received atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Secondary
Stages 1 and 2: Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. SAEs = Serious AEs; AESIs = Adverse Events of Special Interest.
Safety-evaluable population included all participants who received any amount of study treatment. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses.
Posted
Count of Participants
Participants
From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months)
ID
Title
Description
OG000
Stage 1 Cohort 1: Control (Atezolizumab)
Participants received atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG001
Stage 1 Cohort 1: Atezolizumab + Cobimetinib
Time Frame
From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months
Description
AEs, SAEs and AESIs: Safety-evaluable population included all participants who received any amount of study treatment.
All-cause Mortality: Randomized population included all participants randomized to each treatment arm.
The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the safety analyses. No mortality data could be collected for this arm as the participant withdrew from the study before receiving treatment.
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
Stage 1 Cohort 1: Control (Atezolizumab)
Participants received atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
3
3
2
3
3
3
EG001
Stage 1 Cohort 1: Atezolizumab + Cobimetinib
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
3
5
4
5
5
5
EG002
Stage 1 Cohort 1: Atezolizumab + CEA-TCB
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab, 1200 mg, IV on Day 1 and CEA-TCB, 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
0
1
1
1
1
1
EG003
Stage 1 Cohort 1: Atezolizumab + Tiragolumab
Participants received atezolizumab 1200 mg and tiragolumab 600 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up. Cohort 1 was reactivated with 'Atezo + Tira' as a new comparator arm.
1
1
1
1
1
1
EG004
Stage 1 Cohort 2: Control (Docetaxel)
Participants received docetaxel 75 mg/m^2, IV over 60 minutes on Day 1 of each cycle until PD or unacceptable toxicity (cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
36
66
20
61
58
61
EG005
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
10
15
8
15
13
15
EG006
Stage 1 Cohort 2: Atezolizumab + CEA-TCB
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
1
1
1
1
1
1
EG007
Stage 1 Cohort 2: Atezolizumab + CPI-444
Participants received CPI-444 100 mg, PO, BID, on Days 1-21 and atezolizumab, 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
10
16
8
15
14
15
EG008
Stage 1 Cohort 2: Docetaxel + Atezolizumab
Participants received docetaxel 75 mg/m^2 IV over 60 minutes and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
10
18
5
16
16
16
EG009
Stage 1 Cohort 2: Atezolizumab + Ipatasertib
Participants received ipatasertib 400 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
14
31
13
30
30
30
EG010
Stage 1 Cohort 2: Atezolizumab + Bevacizumab
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). Participants also received stereotactic radiotherapy as outlined in the technical radiotherapy manual up to 21 days. After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
23
45
17
43
41
43
EG012
Stage 1 Cohort 2: Atezolizumab + SG
Participants received sacituzumab govitecan 10 mg/kg, IV infusion on Days 1 and 8 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
19
30
14
30
30
30
EG013
Stage 1 Cohort 2: Atezolizumab + Evolocumab
Participants received evolocumab 140 mg, SC injection, and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
25
32
10
31
29
31
EG014
Stage 1 Cohort 2: Atezolizumab + Camonsertib
Participants received camonsertib 160 mg, PO on Days 1-3 and Days 8-10 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Participants received atezolizumab 1200 mg, IV infusions on Day 1 of each cycle, pemetrexed, 500 mg/m^2, IV infusions on Day 1 of each cycle and carboplatin AUC 6 mg/mL/min (Calvert formula dosing), IV infusion on Day 1 of the first four or six cycles, until PD, loss of clinical benefit or unacceptable toxicity (cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
0
2
1
2
2
2
EG016
Stage 2 Cohort 2: Docetaxel + Atezolizumab
Participants received atezolizumab 1200 mg, IV infusions, and docetaxel 75 mg/m^2, IV infusion over 1 hour on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
29
33
13
32
30
32
EG017
Stage 2 Cohort 2: Atezolizumab + Linagliptin
Participants received linagliptin 5 mg, PO, QD on Days 1-21 and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
19
22
6
20
18
20
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA Version 28.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected61 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected15 at risk
EG0081 events1 affected16 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected40 at risk
EG0110 events0 affected43 at risk
EG0120 events0 affected30 at risk
EG0130 events0 affected31 at risk
EG0140 events0 affected8 at risk
EG0150 events0 affected2 at risk
EG0160 events0 affected32 at risk
EG0170 events0 affected20 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Atrial tachycardia
Cardiac disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Cardiogenic shock
Cardiac disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Inappropriate antidiuretic hormone secretion
Endocrine disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Retinal vein occlusion
Eye disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Serous retinal detachment
Eye disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected1 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Gastric perforation
Gastrointestinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Gastrointestinal obstruction
Gastrointestinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Ileus paralytic
Gastrointestinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Asthenia
General disorders
MedDRA Version 28.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Death
General disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Fatigue
General disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
General physical health deterioration
General disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Implant site haematoma
General disorders
MedDRA Version 28.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Oedema peripheral
General disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Pain
General disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Pyrexia
General disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Drug-induced liver injury
Hepatobiliary disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Gallbladder rupture
Hepatobiliary disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Cytokine release syndrome
Immune system disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Abdominal infection
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Arthritis infective
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
COVID-19
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Cellulitis
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Encephalitis herpes
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Enterocolitis infectious
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Infection
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Influenza
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Large intestine infection
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Neutropenic sepsis
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Pneumonia
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Sepsis
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Septic shock
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Skin infection
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Urosepsis
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Procedural pneumothorax
Injury, poisoning and procedural complications
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Radiation necrosis
Injury, poisoning and procedural complications
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Blood creatinine increased
Investigations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Lipase increased
Investigations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Platelet count decreased
Investigations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Transaminases increased
Investigations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Cauda equina syndrome
Nervous system disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Dizziness
Nervous system disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Embolic cerebral infarction
Nervous system disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Encephalitis autoimmune
Nervous system disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Hepatic encephalopathy
Nervous system disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Syncope
Nervous system disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Completed suicide
Psychiatric disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Nephritis
Renal and urinary disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Renal tubular necrosis
Renal and urinary disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Bronchial fistula
Respiratory, thoracic and mediastinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Immune-mediated lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA Version 28.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Capillary leak syndrome
Vascular disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Embolism
Vascular disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Hypotension
Vascular disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Superior vena cava syndrome
Vascular disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA Version 28.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG00423 events21 affected61 at risk
EG0054 events4 affected15 at risk
EG0060 events0 affected1 at risk
EG0076 events5 affected15 at risk
EG0086 events5 affected16 at risk
EG0098 events7 affected30 at risk
EG0104 events2 affected40 at risk
EG0116 events5 affected43 at risk
EG01228 events14 affected30 at risk
EG0136 events6 affected31 at risk
EG01414 events7 affected8 at risk
EG0152 events2 affected2 at risk
EG01627 events10 affected32 at risk
EG0175 events3 affected20 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Hyperleukocytosis
Blood and lymphatic system disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Monocytosis
Blood and lymphatic system disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Blepharitis
Eye disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Cataract
Eye disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Central serous chorioretinopathy
Eye disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Diplopia
Eye disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Dry eye
Eye disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Eyelid oedema
Eye disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Macular thickening
Eye disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Photopsia
Eye disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Vision blurred
Eye disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Chapped lips
Gastrointestinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events2 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events2 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected1 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Intestinal dilatation
Gastrointestinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Lip dry
Gastrointestinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Administration site extravasation
General disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Asthenia
General disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Chest pain
General disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Chills
General disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Fatigue
General disorders
MedDRA Version 28.1
Systematic Assessment
EG0003 events2 affected3 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected1 at risk
EG003
Gait disturbance
General disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Infusion site pain
General disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Localised oedema
General disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Mucosal dryness
General disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Mucosal inflammation
General disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Oedema peripheral
General disorders
MedDRA Version 28.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events2 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Pain
General disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Peripheral swelling
General disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Pyrexia
General disorders
MedDRA Version 28.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Swelling
General disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Swelling face
General disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Biliary obstruction
Hepatobiliary disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Hepatic pain
Hepatobiliary disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected1 at risk
EG003
Abscess limb
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Arthritis bacterial
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Bronchitis
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
COVID-19
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Escherichia infection
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Folliculitis
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Furuncle
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Gastrointestinal viral infection
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Gingivitis
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Infection
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Otitis media
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Pneumonia
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Pneumonia cytomegaloviral
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Rash pustular
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Rhinitis
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Skin candida
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA Version 28.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA Version 28.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Inappropriate schedule of product administration
Injury, poisoning and procedural complications
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Medication error
Injury, poisoning and procedural complications
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Radiation pneumonitis
Injury, poisoning and procedural complications
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected1 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Amylase increased
Investigations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events3 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA Version 28.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Blood creatinine increased
Investigations
MedDRA Version 28.1
Systematic Assessment
EG0003 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Blood glucose increased
Investigations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Blood thyroid stimulating hormone decreased
Investigations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA Version 28.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Body temperature increased
Investigations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
C-reactive protein increased
Investigations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA Version 28.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Intraocular pressure increased
Investigations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Lipase increased
Investigations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Platelet count decreased
Investigations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Weight decreased
Investigations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected5 at risk
EG0020 events0 affected1 at risk
EG003
White blood cell count decreased
Investigations
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA Version 28.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected1 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA Version 28.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA Version 28.1
Systematic Assessment
EG0002 events2 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA Version 28.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events1 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA Version 28.1
Systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 28.1
Systematic Assessment
EG0003 events2 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Clubbing
Musculoskeletal and connective tissue disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA Version 28.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Osteoporotic fracture
Musculoskeletal and connective tissue disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Seborrhoeic keratosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 28.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Dizziness
Nervous system disorders
MedDRA Version 28.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Hyperammonaemic encephalopathy
Nervous system disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Motor dysfunction
Nervous system disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA Version 28.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Neurotoxicity
Nervous system disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Post herpetic neuralgia
Nervous system disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Somnolence
Nervous system disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Syncope
Nervous system disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Tremor
Nervous system disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Vocal cord paralysis
Nervous system disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Device occlusion
Product Issues
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Anger
Psychiatric disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA Version 28.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Depression
Psychiatric disorders
MedDRA Version 28.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA Version 28.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA Version 28.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Urinary hesitation
Renal and urinary disorders
MedDRA Version 28.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA Version 28.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Prostatomegaly
Reproductive system and breast disorders
MedDRA Version 28.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected1 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Rales
Respiratory, thoracic and mediastinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected1 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Dermatitis psoriasiform
Skin and subcutaneous tissue disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Nail discolouration
Skin and subcutaneous tissue disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Neurodermatitis
Skin and subcutaneous tissue disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Onycholysis
Skin and subcutaneous tissue disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected5 at risk
EG0021 events1 affected1 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA Version 28.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0014 events2 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA Version 28.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Skin atrophy
Skin and subcutaneous tissue disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA Version 28.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Stasis dermatitis
Skin and subcutaneous tissue disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Flushing
Vascular disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Hypertension
Vascular disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Hypotension
Vascular disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Jugular vein thrombosis
Vascular disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 at risk
EG003
Thrombosis
Vascular disorders
MedDRA Version 28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected1 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.
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG006
Stage 1 Cohort 2: Atezolizumab + CEA-TCB
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG007
Stage 1 Cohort 2: Atezolizumab + CPI-444
Participants received CPI-444 100 mg, PO, BID, on Days 1-21 and atezolizumab, 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG008
Stage 1 Cohort 2: Docetaxel + Atezolizumab
Participants received docetaxel 75 mg/m^2 IV over 60 minutes and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG009
Stage 1 Cohort 2: Atezolizumab + Ipatasertib
Participants received ipatasertib 400 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG010
Stage 1 Cohort 2: Atezolizumab + Bevacizumab
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). Participants also received stereotactic radiotherapy as outlined in the technical radiotherapy manual up to 21 days. After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG012
Stage 1 Cohort 2: Atezolizumab + SG
Participants received sacituzumab govitecan 10 mg/kg, IV infusion on Days 1 and 8 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG013
Stage 1 Cohort 2: Atezolizumab + Evolocumab
Participants received evolocumab 140 mg, SC injection, and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG014
Stage 1 Cohort 2: Atezolizumab + Camonsertib
Participants received camonsertib 160 mg, PO on Days 1-3 and Days 8-10 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
1
OG00461
OG00515
OG0061
OG00715
OG00816
OG00930
OG01040
OG01136
OG01230
OG01331
OG0148
0
(0.00 to 97.50)
OG00413.1(5.84 to 24.22)
OG0050(0.00 to 21.80)
OG0060(0.00 to 97.50)
OG0076.7(0.17 to 31.95)
OG0086.3(0.16 to 30.23)
OG0096.7(0.82 to 22.07)
OG01020.0(9.05 to 35.65)
OG01116.7(6.37 to 32.81)
OG0126.7(0.82 to 22.07)
OG0133.2(0.08 to 16.70)
OG0140(0.00 to 36.94)
Difference in Overall Response Rates
-13.11
2-Sided
95
-25.74
-0.49
Superiority
OG004
OG007
Difference in Overall Response Rates
-6.45
2-Sided
95
-25.80
12.91
Superiority
OG004
OG008
Difference in Overall Response Rates
-6.86
2-Sided
95
-25.38
11.66
Superiority
OG004
OG009
Difference in Overall Response Rates
-6.45
2-Sided
95
-21.24
8.34
Superiority
OG004
OG010
Difference in Overall Response Rates
6.89
2-Sided
95
-10.20
23.97
Superiority
OG004
OG011
Difference in Overall Response Rates
3.55
2-Sided
95
-13.49
20.59
Superiority
OG004
OG012
Difference in Overall Response Rates
-6.45
2-Sided
95
-21.24
8.34
Superiority
OG004
OG013
Difference in Overall Response Rates
-9.89
2-Sided
95
-22.83
3.05
Superiority
OG004
OG014
Difference in Overall Response Rates
-13.11
2-Sided
95
-28.66
2.43
Superiority
OG001
Stage 1 Cohort 1: Atezolizumab + Cobimetinib
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG002
Stage 1 Cohort 1: Atezolizumab + CEA-TCB
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab, 1200 mg, IV on Day 1 and CEA-TCB, 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG003
Stage 1 Cohort 1: Atezolizumab + Tiragolumab
Participants received atezolizumab 1200 mg and tiragolumab 600 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up. Cohort 1 was reactivated with 'Atezo + Tira' as a new comparator arm.
OG004
Stage 1 Cohort 2: Control (Docetaxel)
Participants received docetaxel 75 mg/m^2, IV over 60 minutes on Day 1 of each cycle until PD or unacceptable toxicity (cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG005
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG006
Stage 1 Cohort 2: Atezolizumab + CEA-TCB
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG007
Stage 1 Cohort 2: Atezolizumab + CPI-444
Participants received CPI-444 100 mg, PO, BID, on Days 1-21 and atezolizumab, 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG008
Stage 1 Cohort 2: Docetaxel + Atezolizumab
Participants received docetaxel 75 mg/m^2 IV over 60 minutes and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG009
Stage 1 Cohort 2: Atezolizumab + Ipatasertib
Participants received ipatasertib 400 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG010
Stage 1 Cohort 2: Atezolizumab + Bevacizumab
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). Participants also received stereotactic radiotherapy as outlined in the technical radiotherapy manual up to 21 days. After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG012
Stage 1 Cohort 2: Atezolizumab + SG
Participants received sacituzumab govitecan 10 mg/kg, IV infusion on Days 1 and 8 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG013
Stage 1 Cohort 2: Atezolizumab + Evolocumab
Participants received evolocumab 140 mg, SC injection, and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG014
Stage 1 Cohort 2: Atezolizumab + Camonsertib
Participants received camonsertib 160 mg, PO on Days 1-3 and Days 8-10 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Units
Counts
Participants
OG0003
OG0015
OG0021
OG0031
OG00461
OG00515
OG0061
OG00715
OG00816
OG00930
OG01040
OG01136
OG01230
OG01331
OG0148
Title
Denominators
Categories
Title
Measurements
OG0001.51(1.31 to NA)Upper limit of 95% confidence interval (CI) was not estimable due to an insufficient number of participants with events.
OG0012.66(0.69 to NA)Upper limit of 95% CI was not estimable due to an insufficient number of participants with events.
OG0026.90(NA to NA)95% CI was not estimable due to an insufficient number of participants with events.
OG0031.64(NA to NA)95% CI was not estimable due to an insufficient number of participants with events.
OG0044.83(4.11 to 5.91)
OG0052.43(1.84 to 6.77)
OG00617.48(NA to NA)95% CI was not estimable due to an insufficient number of participants with events.
OG0072.30(1.38 to 5.52)
OG0085.09(3.22 to 8.54)
OG0092.64(1.71 to 3.98)
OG0106.95(4.37 to 8.28)
OG0117.93(4.67 to 15.67)
OG0125.49(4.27 to 7.16)
OG0132.17(1.48 to 4.37)
OG0143.50(1.54 to 5.75)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Hazard Ratio (HR)
1.34
2-Sided
95
0.25
7.09
Superiority
OG004
OG005
Hazard Ratio (HR)
1.53
2-Sided
95
0.80
2.91
Superiority
OG004
OG007
Hazard Ratio (HR)
1.29
2-Sided
95
0.70
2.37
Superiority
OG004
OG008
Hazard Ratio (HR)
1.06
2-Sided
95
0.60
1.88
Superiority
OG004
OG009
Hazard Ratio (HR)
1.74
2-Sided
95
1.09
2.77
Superiority
OG004
OG010
Hazard Ratio (HR)
0.84
2-Sided
95
0.55
1.30
Superiority
OG004
OG011
Hazard Ratio (HR)
0.57
2-Sided
95
0.36
0.92
Superiority
OG004
OG012
Hazard Ratio (HR)
0.89
2-Sided
95
0.55
1.42
Superiority
OG004
OG013
Hazard Ratio (HR)
1.80
2-Sided
95
1.14
2.86
Superiority
OG004
OG014
Hazard Ratio (HR)
1.68
2-Sided
95
0.79
3.61
Superiority
OG001
Stage 1 Cohort 1: Atezolizumab + Cobimetinib
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG002
Stage 1 Cohort 1: Atezolizumab + CEA-TCB
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab, 1200 mg, IV on Day 1 and CEA-TCB, 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG003
Stage 1 Cohort 1: Atezolizumab + Tiragolumab
Participants received atezolizumab 1200 mg and tiragolumab 600 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up. Cohort 1 was reactivated with 'Atezo + Tira' as a new comparator arm.
OG004
Stage 1 Cohort 2: Control (Docetaxel)
Participants received docetaxel 75 mg/m^2, IV over 60 minutes on Day 1 of each cycle until PD or unacceptable toxicity (cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG005
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG006
Stage 1 Cohort 2: Atezolizumab + CEA-TCB
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG007
Stage 1 Cohort 2: Atezolizumab + CPI-444
Participants received CPI-444 100 mg, PO, BID, on Days 1-21 and atezolizumab, 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG008
Stage 1 Cohort 2: Docetaxel + Atezolizumab
Participants received docetaxel 75 mg/m^2 IV over 60 minutes and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG009
Stage 1 Cohort 2: Atezolizumab + Ipatasertib
Participants received ipatasertib 400 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG010
Stage 1 Cohort 2: Atezolizumab + Bevacizumab
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). Participants also received stereotactic radiotherapy as outlined in the technical radiotherapy manual up to 21 days. After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG012
Stage 1 Cohort 2: Atezolizumab + SG
Participants received sacituzumab govitecan 10 mg/kg, IV infusion on Days 1 and 8 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG013
Stage 1 Cohort 2: Atezolizumab + Evolocumab
Participants received evolocumab 140 mg, SC injection, and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG014
Stage 1 Cohort 2: Atezolizumab + Camonsertib
Participants received camonsertib 160 mg, PO on Days 1-3 and Days 8-10 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Units
Counts
Participants
OG0003
OG0015
OG0021
OG0031
OG00461
OG00515
OG0061
OG00715
OG00816
OG00930
OG01040
OG01136
OG01230
OG01331
OG0148
Title
Denominators
Categories
Title
Measurements
OG00033.33(0.00 to 86.68)
OG00120.00(0.00 to 55.06)
OG002100.00(100.00 to 100.00)
OG003NA(NA to NA)Percentage and 95% CI could not be estimated because the participant was censored prior to 6 months.
OG00436.79(23.61 to 49.96)
OG00529.22(3.33 to 55.11)
OG006100.00(100.00 to 100.00)
OG00726.67(4.29 to 49.05)
OG00837.50(13.78 to 61.22)
OG00920.00(5.69 to 34.31)
OG01055.00(39.58 to 70.42)
OG01161.11(45.19 to 77.04)
OG01243.33(25.60 to 61.07)
OG01312.90(1.10 to 24.70)
OG01412.50(0.00 to 35.42)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Difference in Event Free Rate
-13.33
2-Sided
95
-77.17
50.50
Superiority
OG004
OG005
Difference in Event Free Rate
-7.56
2-Sided
95
-36.61
21.48
Superiority
OG004
OG007
Difference in Event Free Rate
-10.12
2-Sided
95
-36.09
15.85
Superiority
OG004
OG008
Difference in Event Free Rate
0.71
2-Sided
95
-26.42
27.85
Superiority
OG004
OG009
Difference in Event Free Rate
-16.79
2-Sided
95
-36.24
2.67
Superiority
OG004
OG010
Difference in Event Free Rate
18.21
2-Sided
95
-2.07
38.50
Superiority
OG004
OG011
Difference in Event Free Rate
24.33
2-Sided
95
3.66
44.99
Superiority
OG004
OG012
Difference in Event Free Rate
6.55
2-Sided
95
-15.54
28.64
Superiority
OG004
OG013
Difference in Event Free Rate
-23.88
2-Sided
95
-41.57
-6.19
Superiority
OG004
OG014
Difference in Event Free Rate
-24.29
2-Sided
95
-50.72
2.15
Superiority
OG002
Stage 1 Cohort 1: Atezolizumab + CEA-TCB
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab, 1200 mg, IV on Day 1 and CEA-TCB, 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG003
Stage 1 Cohort 1: Atezolizumab + Tiragolumab
Participants received atezolizumab 1200 mg and tiragolumab 600 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up. Cohort 1 was reactivated with 'Atezo + Tira' as a new comparator arm.
OG004
Stage 1 Cohort 2: Control (Docetaxel)
Participants received docetaxel 75 mg/m^2, IV over 60 minutes on Day 1 of each cycle until PD or unacceptable toxicity (cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG005
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG006
Stage 1 Cohort 2: Atezolizumab + CEA-TCB
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG007
Stage 1 Cohort 2: Atezolizumab + CPI-444
Participants received CPI-444 100 mg, PO, BID, on Days 1-21 and atezolizumab, 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG008
Stage 1 Cohort 2: Docetaxel + Atezolizumab
Participants received docetaxel 75 mg/m^2 IV over 60 minutes and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG009
Stage 1 Cohort 2: Atezolizumab + Ipatasertib
Participants received ipatasertib 400 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG010
Stage 1 Cohort 2: Atezolizumab + Bevacizumab
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). Participants also received stereotactic radiotherapy as outlined in the technical radiotherapy manual up to 21 days. After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG012
Stage 1 Cohort 2: Atezolizumab + SG
Participants received sacituzumab govitecan 10 mg/kg, IV infusion on Days 1 and 8 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG013
Stage 1 Cohort 2: Atezolizumab + Evolocumab
Participants received evolocumab 140 mg, SC injection, and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG014
Stage 1 Cohort 2: Atezolizumab + Camonsertib
Participants received camonsertib 160 mg, PO on Days 1-3 and Days 8-10 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Units
Counts
Participants
OG0003
OG0015
OG0021
OG0031
OG00461
OG00515
OG0061
OG00715
OG00816
OG00930
OG01040
OG01136
OG01230
OG01331
OG0148
Title
Denominators
Categories
Title
Measurements
OG0002.96(2.30 to NA)Upper limit of 95% CI was not estimable due to an insufficient number of participants with events.
OG00132.66(10.94 to NA)Upper limit of 95% CI was not estimable due to an insufficient number of participants with events.
OG002NA(NA to NA)Median and 95% CI were not estimable due to an insufficient number of participants with events.
OG0033.48(NA to NA)95% CI was not estimable due to an insufficient number of participants with events.
OG0049.63(8.34 to 14.78)
OG0057.75(1.91 to 16.56)
OG00617.48(NA to NA)95% CI was not estimable due to an insufficient number of participants with events.
OG00711.53(2.07 to 17.22)
OG0089.40(4.63 to 23.59)
OG00912.45(5.59 to 15.51)
OG01013.70(10.61 to 21.06)
OG01116.92(9.76 to 33.71)
OG01212.48(7.62 to 17.64)
OG0139.10(7.82 to 14.55)
OG014NA(6.21 to NA)Median and upper limit of 95% CI were not estimable due to an insufficient number of participants with events.
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Hazard Ratio (HR)
0.64
2-Sided
95
0.10
4.11
Superiority
OG004
OG005
Hazard Ratio (HR)
1.60
2-Sided
95
0.80
3.20
Superiority
OG004
OG007
Hazard Ratio (HR)
0.94
2-Sided
95
0.49
1.82
Superiority
OG004
OG008
Hazard Ratio (HR)
0.97
2-Sided
95
0.51
1.85
Superiority
OG004
OG009
Hazard Ratio (HR)
1.05
2-Sided
95
0.64
1.75
Superiority
OG004
OG010
Hazard Ratio (HR)
0.73
2-Sided
95
0.46
1.15
Superiority
OG004
OG011
Hazard Ratio (HR)
0.54
2-Sided
95
0.32
0.90
Superiority
OG004
OG012
Hazard Ratio (HR)
0.95
2-Sided
95
0.59
1.54
Superiority
OG004
OG013
Hazard Ratio (HR)
1.29
2-Sided
95
0.79
2.11
Superiority
OG004
OG014
Hazard Ratio (HR)
0.79
2-Sided
95
0.28
2.23
Superiority
OG002
Stage 1 Cohort 1: Atezolizumab + CEA-TCB
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab, 1200 mg, IV on Day 1 and CEA-TCB, 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG003
Stage 1 Cohort 1: Atezolizumab + Tiragolumab
Participants received atezolizumab 1200 mg and tiragolumab 600 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up. Cohort 1 was reactivated with 'Atezo + Tira' as a new comparator arm.
OG004
Stage 1 Cohort 2: Control (Docetaxel)
Participants received docetaxel 75 mg/m^2, IV over 60 minutes on Day 1 of each cycle until PD or unacceptable toxicity (cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG005
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG006
Stage 1 Cohort 2: Atezolizumab + CEA-TCB
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG007
Stage 1 Cohort 2: Atezolizumab + CPI-444
Participants received CPI-444 100 mg, PO, BID, on Days 1-21 and atezolizumab, 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG008
Stage 1 Cohort 2: Docetaxel + Atezolizumab
Participants received docetaxel 75 mg/m^2 IV over 60 minutes and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG009
Stage 1 Cohort 2: Atezolizumab + Ipatasertib
Participants received ipatasertib 400 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG010
Stage 1 Cohort 2: Atezolizumab + Bevacizumab
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). Participants also received stereotactic radiotherapy as outlined in the technical radiotherapy manual up to 21 days. After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG012
Stage 1 Cohort 2: Atezolizumab + SG
Participants received sacituzumab govitecan 10 mg/kg, IV infusion on Days 1 and 8 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG013
Stage 1 Cohort 2: Atezolizumab + Evolocumab
Participants received evolocumab 140 mg, SC injection, and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG014
Stage 1 Cohort 2: Atezolizumab + Camonsertib
Participants received camonsertib 160 mg, PO on Days 1-3 and Days 8-10 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Units
Counts
Participants
OG0003
OG0015
OG0021
OG0031
OG00461
OG00515
OG0061
OG00715
OG00816
OG00930
OG01040
OG01136
OG01230
OG01331
OG0148
Title
Denominators
Categories
Title
Measurements
OG00033.33(0.00 to 86.68)
OG001100.00(100.00 to 100.00)
OG002100.00(100.00 to 100.00)
OG003NA(NA to NA)Percentage and 95% CI could not be estimated because the participant was censored prior to 6 months.
OG00478.34(67.47 to 89.20)
OG00553.85(26.02 to 81.67)
OG006100.00(100.00 to 100.00)
OG00760.00(35.21 to 84.79)
OG00868.18(45.06 to 91.30)
OG00966.92(49.21 to 84.64)
OG01082.50(70.72 to 94.28)
OG01181.82(68.66 to 94.98)
OG01279.62(65.04 to 94.19)
OG01375.62(59.87 to 91.37)
OG01487.50(64.58 to 100.00)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Difference in Event Free Rate
66.67
2-Sided
95
13.32
120.01
Superiority
OG004
OG005
Difference in Event Free Rate
-24.49
2-Sided
95
-54.36
5.38
Superiority
OG004
OG007
Difference in Event Free Rate
-18.34
2-Sided
95
-45.41
8.73
Superiority
OG004
OG008
Difference in Event Free Rate
-10.15
2-Sided
95
-35.70
15.39
Superiority
OG004
OG009
Difference in Event Free Rate
-11.41
2-Sided
95
-32.20
9.37
Superiority
OG004
OG010
Difference in Event Free Rate
4.16
2-Sided
95
-11.86
20.19
Superiority
OG004
OG011
Difference in Event Free Rate
3.48
2-Sided
95
-13.59
20.55
Superiority
OG004
OG012
Difference in Event Free Rate
1.28
2-Sided
95
-16.90
19.46
Superiority
OG004
OG013
Difference in Event Free Rate
-2.72
2-Sided
95
-21.86
16.42
Superiority
OG004
OG014
Difference in Event Free Rate
9.16
2-Sided
95
-16.20
34.53
Superiority
Participants received atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG001
Stage 1 Cohort 1: Atezolizumab + Cobimetinib
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG002
Stage 1 Cohort 1: Atezolizumab + CEA-TCB
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab, 1200 mg, IV on Day 1 and CEA-TCB, 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG003
Stage 1 Cohort 1: Atezolizumab + Tiragolumab
Participants received atezolizumab 1200 mg and tiragolumab 600 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up. Cohort 1 was reactivated with 'Atezo + Tira' as a new comparator arm.
OG004
Stage 1 Cohort 2: Control (Docetaxel)
Participants received docetaxel 75 mg/m^2, IV over 60 minutes on Day 1 of each cycle until PD or unacceptable toxicity (cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG005
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG006
Stage 1 Cohort 2: Atezolizumab + CEA-TCB
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG007
Stage 1 Cohort 2: Atezolizumab + CPI-444
Participants received CPI-444 100 mg, PO, BID, on Days 1-21 and atezolizumab, 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG008
Stage 1 Cohort 2: Docetaxel + Atezolizumab
Participants received docetaxel 75 mg/m^2 IV over 60 minutes and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG009
Stage 1 Cohort 2: Atezolizumab + Ipatasertib
Participants received ipatasertib 400 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG010
Stage 1 Cohort 2: Atezolizumab + Bevacizumab
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). Participants also received stereotactic radiotherapy as outlined in the technical radiotherapy manual up to 21 days. After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG012
Stage 1 Cohort 2: Atezolizumab + SG
Participants received sacituzumab govitecan 10 mg/kg, IV infusion on Days 1 and 8 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG013
Stage 1 Cohort 2: Atezolizumab + Evolocumab
Participants received evolocumab 140 mg, SC injection, and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG014
Stage 1 Cohort 2: Atezolizumab + Camonsertib
Participants received camonsertib 160 mg, PO on Days 1-3 and Days 8-10 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Units
Counts
Participants
OG0001
OG0010
OG0021
OG0030
OG0048
OG0050
OG0060
OG0071
OG0081
OG0092
OG0108
OG0116
OG0122
OG0131
OG0140
Title
Denominators
Categories
Title
Measurements
OG00030.39(NA to NA)95% CI was not estimable due to an insufficient number of participants with events.
OG0025.36(NA to NA)95% CI was not estimable due to an insufficient number of participants with events.
OG0047.03(3.48 to NA)Upper limit of 95% CI was not estimable due to an insufficient number of participants with events.
OG00719.09(NA to NA)95% CI was not estimable due to an insufficient number of participants with events.
OG00816.20(NA to NA)95% CI was not estimable due to an insufficient number of participants with events.
OG0094.17(1.41 to NA)Upper limit of 95% CI was not estimable due to an insufficient number of participants with events.
OG01014.54(5.13 to 16.62)
OG01120.99(11.10 to NA)Upper limit of 95% CI was not estimable due to an insufficient number of participants with events.
OG0125.36(4.17 to NA)Upper limit of 95% CI was not estimable due to an insufficient number of participants with events.
OG01323.26(NA to NA)95% CI was not estimable due to an insufficient number of participants with events.
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG004
OG007
Hazard Ratio (HR)
0.56
2-Sided
95
0.06
5.23
Superiority
OG004
OG008
Hazard Ratio (HR)
0.56
2-Sided
95
0.06
5.23
Superiority
OG004
OG009
Hazard Ratio (HR)
3.17
2-Sided
95
0.52
19.32
Superiority
OG004
OG010
Hazard Ratio (HR)
0.69
2-Sided
95
0.21
2.23
Superiority
OG004
OG011
Hazard Ratio (HR)
0.33
2-Sided
95
0.07
1.45
Superiority
OG004
OG012
Hazard Ratio (HR)
2.19
2-Sided
95
0.36
13.25
Superiority
OG004
OG013
Hazard Ratio (HR)
0.56
2-Sided
95
0.06
5.23
Superiority
OG001
Stage 1 Cohort 1: Atezolizumab + Cobimetinib
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG002
Stage 1 Cohort 1: Atezolizumab + CEA-TCB
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab, 1200 mg, IV on Day 1 and CEA-TCB, 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG003
Stage 1 Cohort 1: Atezolizumab + Tiragolumab
Participants received atezolizumab 1200 mg and tiragolumab 600 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up. Cohort 1 was reactivated with 'Atezo + Tira' as a new comparator arm.
OG004
Stage 1 Cohort 2: Control (Docetaxel)
Participants received docetaxel 75 mg/m^2, IV over 60 minutes on Day 1 of each cycle until PD or unacceptable toxicity (cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG005
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG006
Stage 1 Cohort 2: Atezolizumab + CEA-TCB
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG007
Stage 1 Cohort 2: Atezolizumab + CPI-444
Participants received CPI-444 100 mg, PO, BID, on Days 1-21 and atezolizumab, 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG008
Stage 1 Cohort 2: Docetaxel + Atezolizumab
Participants received docetaxel 75 mg/m^2 IV over 60 minutes and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG009
Stage 1 Cohort 2: Atezolizumab + Ipatasertib
Participants received ipatasertib 400 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG010
Stage 1 Cohort 2: Atezolizumab + Bevacizumab
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). Participants also received stereotactic radiotherapy as outlined in the technical radiotherapy manual up to 21 days. After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG012
Stage 1 Cohort 2: Atezolizumab + SG
Participants received sacituzumab govitecan 10 mg/kg, IV infusion on Days 1 and 8 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG013
Stage 1 Cohort 2: Atezolizumab + Evolocumab
Participants received evolocumab 140 mg, SC injection, and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG014
Stage 1 Cohort 2: Atezolizumab + Camonsertib
Participants received camonsertib 160 mg, PO on Days 1-3 and Days 8-10 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Units
Counts
Participants
OG0003
OG0015
OG0021
OG0031
OG00461
OG00515
OG0061
OG00715
OG00816
OG00930
OG01040
OG01136
OG01230
OG01331
OG0148
Title
Denominators
Categories
Title
Measurements
OG00033.3(0.84 to 90.57)
OG00140.0(5.27 to 85.34)
OG002100(2.50 to 100.00)
OG0030(0.00 to 97.50)
OG00457.4(44.06 to 69.96)
OG00533.3(11.82 to 61.62)
OG006100(2.50 to 100.00)
OG00740.0(16.34 to 67.71)
OG00856.3(29.88 to 80.25)
OG00936.7(19.93 to 56.14)
OG01065.0(48.32 to 79.37)
OG01169.4(51.89 to 83.65)
OG01266.7(47.19 to 82.71)
OG01341.9(24.55 to 60.92)
OG01437.5(8.52 to 75.51)
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG002
Stage 1 Cohort 1: Atezolizumab + CEA-TCB
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab, 1200 mg, IV on Day 1 and CEA-TCB, 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG003
Stage 1 Cohort 1: Atezolizumab + Tiragolumab
Participants received atezolizumab 1200 mg and tiragolumab 600 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up. Cohort 1 was reactivated with 'Atezo + Tira' as a new comparator arm.
OG004
Stage 1 Cohort 2: Control (Docetaxel)
Participants received docetaxel 75 mg/m^2, IV over 60 minutes on Day 1 of each cycle until PD or unacceptable toxicity (cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG005
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
Participants received cobimetinib 60 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG006
Stage 1 Cohort 2: Atezolizumab + CEA-TCB
Participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 40 mg, IV on Day 1, 80 mg, IV on Day 8 and 100 mg, IV on Day 15 of Cycle 1. For subsequent cycles, participants received atezolizumab 1200 mg, IV on Day 1 and CEA-TCB 150 mg, IV on Days 1, 8 and 15 until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG007
Stage 1 Cohort 2: Atezolizumab + CPI-444
Participants received CPI-444 100 mg, PO, BID, on Days 1-21 and atezolizumab, 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG008
Stage 1 Cohort 2: Docetaxel + Atezolizumab
Participants received docetaxel 75 mg/m^2 IV over 60 minutes and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until PD, loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG009
Stage 1 Cohort 2: Atezolizumab + Ipatasertib
Participants received ipatasertib 400 mg, PO, QD on Days 1-21 and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG010
Stage 1 Cohort 2: Atezolizumab + Bevacizumab
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Participants received atezolizumab 1200 mg, IV infusions, and bevacizumab 15 mg/kg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). Participants also received stereotactic radiotherapy as outlined in the technical radiotherapy manual up to 21 days. After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG012
Stage 1 Cohort 2: Atezolizumab + SG
Participants received sacituzumab govitecan 10 mg/kg, IV infusion on Days 1 and 8 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG013
Stage 1 Cohort 2: Atezolizumab + Evolocumab
Participants received evolocumab 140 mg, SC injection, and atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
OG014
Stage 1 Cohort 2: Atezolizumab + Camonsertib
Participants received camonsertib 160 mg, PO on Days 1-3 and Days 8-10 of each cycle and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until loss of clinical benefit or unacceptable toxicity (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.
Participants received atezolizumab 1200 mg, IV infusions on Day 1 of each cycle, pemetrexed, 500 mg/m^2, IV infusions on Day 1 of each cycle and carboplatin AUC 6 mg/mL/min (Calvert formula dosing), IV infusion on Day 1 of the first four or six cycles, until PD, loss of clinical benefit or unacceptable toxicity (cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
OG016
Stage 2 Cohort 2: Docetaxel + Atezolizumab
Participants received atezolizumab 1200 mg, IV infusions, and docetaxel 75 mg/m^2, IV infusion over 1 hour on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
OG017
Stage 2 Cohort 2: Atezolizumab + Linagliptin
Participants received linagliptin 5 mg, PO, QD on Days 1-21 and atezolizumab 1200 mg, IV infusions on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.