A Study Evaluating the Efficacy and Safety of Multiple Im... | NCT03555149 | Trialant
NCT03555149
Sponsor
Hoffmann-La Roche
Status
Terminated
Last Update Posted
Nov 7, 2023Actual
Enrollment
96Actual
Phase
Phase 1Phase 2
Conditions
Colorectal Cancer
Interventions
Regorafenib
Atezolizumab
Imprime PGG
Bevacizumab
Isatuximab
Selicrelumab
Idasanutlin
AB928
LOAd703
Countries
United States
Australia
France
South Korea
Switzerland
Protocol Section
Identification Module
NCT ID
NCT03555149
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CO39612
Secondary IDs
ID
Type
Description
Link
2017-004566-99
EudraCT Number
Brief Title
A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Colorectal Cancer (Morpheus-CRC)
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 Colorectal Cancer (Morpheus-CRC)
Acronym
Not provided
Organization
Hoffmann-La RocheINDUSTRY
Status Module
Record Verification Date
Nov 2023
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The Sponsor made the decision to terminate the study due to start up and recruitment issues caused by limited resource availability at the treating centers.
Expanded Access Info
No
Start Date
Sep 27, 2018Actual
Primary Completion Date
Sep 26, 2022Actual
Completion Date
Sep 26, 2022Actual
First Submitted Date
May 31, 2018
First Submission Date that Met QC Criteria
May 31, 2018
First Posted Date
Jun 13, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Sep 22, 2023
Results First Submitted that Met QC Criteria
Nov 6, 2023
Results First Posted Date
Nov 7, 2023Actual
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
Nov 6, 2023
Last Update Posted Date
Nov 7, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Hoffmann-La RocheINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
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
A phase Ib/II, open-label, multicenter, randomized study designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations in patients with metastatic colorectal cancer (mCRC) that became refractory to first- and second-line standard therapies. Eligible patients will be assigned to one of several treatment arms.
Detailed Description
Not provided
Conditions Module
Conditions
Colorectal Cancer
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
96Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Regorafenib (Control)
Active Comparator
Participants will receive treatment until unacceptable toxicity or disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Drug: Regorafenib
Atezolizumab + Imprime PGG + Bevacizumab
Experimental
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
Drug: Atezolizumab
Drug: Imprime PGG
Drug: Bevacizumab
Atezolizumab + Isatuximab
Experimental
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
Drug: Atezolizumab
Drug: Isatuximab
Atezolizumab + Selicrelumab + Bevacizumab
Experimental
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
Drug: Atezolizumab
Drug: Bevacizumab
Drug: Selicrelumab
Atezolizumab + Idasanutlin
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Regorafenib
Drug
Regorafenib will be administered orally on Days 1-21 of each 28-day cycle.
Atezolizumab + Regorafenib
Atezolizumab + Regorafenib + AB928
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Best Confirmed Overall Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
The best confirmed overall response rate (ORR) is defined as the percentage of participants with a complete response or partial response on two consecutive occasions ≥4 weeks apart, as determined by the investigator according to RECIST v1.1. Participants could be classified as "Stable Disease" if the assessment was at least 6 weeks from randomization. Participants were classified as Missing if no post-baseline response assessments were available. Participants were classified as Not Evaluable if all post-baseline response assessments were unevaluable. The differences in ORR between the experimental arms and the corresponding control arm were calculated, along with 95% confidence intervals (CIs), using normal approximation of the binomial distribution. The 95% CIs for ORRs were constructed using the Clopper-Pearson method. The 95% CIs for the difference in rates were constructed using the Wald method with continuity correction.
From randomization until disease progression or loss of clinical benefit (up to 4 years)
Secondary Outcomes
Measure
Description
Time Frame
Progression-Free Survival (PFS) as Determined by Investigator According to RECIST v1.1
Progression-free survival (PFS) after randomization, defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), was determined by the investigator according to RECIST v1.1. For participants who did not have documented disease progression or death, PFS was censored at the day of the last tumor assessment. The Kaplan-Meier method was used to estimate the median for PFS with 95% confidence intervals (CIs) constructed through use of the Brookmeyer and Crowley method.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Life expectancy ≥ 3 months, as determined by the investigator
Histologically confirmed adenocarcinoma originating from the colon or rectum
Metastatic disease not amenable to local treatment
Disease progression during or following not more than two separate lines of treatment for metastatic colorectal cancer (mCRC) that consisted of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy in combination with a biologic agent
Measurable disease (at least one target lesion) according to RECIST v1.1
Adequate hematologic and end-organ function obtained within 14 days prior to initiation of study treatment
Exclusion Criteria:
High microsatellite instability (MSI-H) tumor
Presence of BRAFV600E mutation
Prior treatment with any of the protocol-specified study treatments
Prior treatment with T-cell co-stimulating or immune checkpoint blockade therapies including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
Biologic treatment within 2 weeks prior to initiation of study treatment, or other systemic treatment for CRC within 2 weeks or 5 half-lives of the drug (whichever is shorter) prior to initiation of study treatment
Treatment with investigational therapy within 28 days prior to initiation of study treatment
Eligibility only for the control arm
Prior allogeneic stem cell or solid organ transplantation
Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to the initiation of study treatment
Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressant medication during study treatment
Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the last dose of atezolizumab
Current treatment with anti-viral therapy for HBV
Uncontrolled pleural effusion, pericardial effusion, ascites requiring recurrent drainage procedures (once monthly or more frequently), or tumor related-pain,
Uncontrolled or symptomatic hypercalcemia (ionized calcium >1.5 mmol/L, calcium >12 mg/dL, or corrected serum calcium >ULN)
Symptomatic, untreated, or actively progressing CNS metastases
History of leptomeningeal disease
Active or history of autoimmune disease or immune deficiency
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
History of malignancy other than CRC within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
Active tuberculosis
Severe infection within 4 weeks prior to initiation of study treatment
Significant cardiovascular disease
Grade ≥3 hemorrhage or bleeding event within 28 days prior to initiation of study treatment
Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
History of severe allergic reactions to chimeric or humanized antibodies or fusion proteins
Inability to swallow medications
Malabsorption condition that would alter the absorption of orally administered medications
Evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding
Urine dipstick ≥ 2+ protein or ≥ 3.5 g of protein in a 24-hour urine collection
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
City of Hope Comprehensive Cancer Center
Duarte
California
91010
United States
Yale University
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
The study was conducted at 15 centers in 5 countries: United States, France, Republic of Korea, Australia, and Switzerland.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Regorafenib (Control)
Participants will receive treatment until unacceptable toxicity or disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
FG001
Atezolizumab + Imprime PGG + Bevacizumab
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Mar 22, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Spain
United Kingdom
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
Experimental
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
Drug: Atezolizumab
Drug: Idasanutlin
Atezolizumab + Regorafenib
Experimental
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
Drug: Regorafenib
Drug: Atezolizumab
Atezolizumab + Regorafenib + AB928
Experimental
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
Drug: Regorafenib
Drug: Atezolizumab
Drug: AB928
Atezolizumab + LOAd703
Experimental
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
Drug: Atezolizumab
Genetic: LOAd703
Regorafenib (Control)
Atezolizumab
Drug
Atezolizumab will be administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of 21-day cycles, with the exception of the Atezolizumab + Selicrelumab + Bevacizumab, Atezolizumab + Idasanutlin, Atezolizumab + Regorafenib and Atezolizumab + Regorafenib + AB928 arms where the Atezolizumab will be administered by IV infusion every 2 weeks (Q2W) on Days 1 and 15 of each 28-day cycle.
Atezolizumab + Idasanutlin
Atezolizumab + Imprime PGG + Bevacizumab
Atezolizumab + Isatuximab
Atezolizumab + LOAd703
Atezolizumab + Regorafenib
Atezolizumab + Regorafenib + AB928
Atezolizumab + Selicrelumab + Bevacizumab
Imprime PGG
Drug
Imprime PGG will be administered by IV infusion weekly on Days 1, 8, and 15 of each 21-day cycle.
Atezolizumab + Imprime PGG + Bevacizumab
Bevacizumab
Drug
Bevacizumab will be administered by IV infusion on Day 1 of each 21-day cycle for the Atezolizumab + Imprime PGG + Bevacizumab arm, and on Day 1 and Day 15 of each 28-day cycle for the Atezolizumab + Selicrelumab + Bevacizumab arm.
Atezolizumab + Imprime PGG + Bevacizumab
Atezolizumab + Selicrelumab + Bevacizumab
Isatuximab
Drug
Isatuximab will be administered on Day 1, 8 and 15 of cycle 1 and on day 1 of all subsequent cycles. Cycles will be 21 days long.
Atezolizumab + Isatuximab
Selicrelumab
Drug
Selicrelumab will be administered by subcutaneous (SC) injection on Day 1 of cycles 1-4 and every third cycle thereafter. Cycles will be 28 days long.
Atezolizumab + Selicrelumab + Bevacizumab
Idasanutlin
Drug
Idasanutlin will be administered orally on Days 1-5 of each 28-day cycle.
Atezolizumab + Idasanutlin
AB928
Drug
AB928 will be administered orally once daily on Days 1-28 of each 28-day cycle.
Atezolizumab + Regorafenib + AB928
LOAd703
Genetic
LOAd703 will be administered by intratumoral injection on Day 1 of each 21-day cycle.
Atezolizumab + LOAd703
Delolimogene mupadenorepvec
From randomization up to the first occurrence of disease or death from any cause (up to 4 years)
Overall Survival (OS)
Overall survival (OS) is 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 method was used to estimate the median for OS with 95% confidence intervals (CIs) constructed through use of the Brookmeyer and Crowley method.
From randomization up to death from any cause (up to 4 years)
Percentage of Participants Who Were Alive at Landmark Timepoints for Overall Survival (OS)
Overall survival (OS) is 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. OS is shown as the percentage of participants who were event-free at the landmark timepoints of 3, 6, 12, and 18 months.
3, 6, 12, and 18 months
Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1
Duration of response is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause.
From the date of first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 4 years)
Disease Control Rate (DCR), as Determined by the Investigator Per RECIST v1.1
Disease control rate is defined as the percentage of participants with stable disease for ≥12 weeks or a complete or partial response, as determined by the investigator according to RECIST v1.1.
From randomization until disease progression or loss of clinical benefit (up to 4 years)
Percentage of Participants With at Least One Adverse Event (AE)
The incidence, nature, and severity of adverse events (AEs) are reported, with severity determined according to NCI CTCAE v4.0. All AEs were reported until 30 days after the last study dose or until start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest were reported until 135 days (or 180 days for the Atezolizumab + LOAd703 arm only) after the last dose of study treatment.
Adverse event data were collected from baseline up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from baseline through survival follow-up (up to 4 years)
New Haven
Connecticut
06511
United States
Dana Farber Cancer Institute
Boston
Massachusetts
02215
United States
Washington University School of Medicine
St Louis
Missouri
63110
United States
Columbia University Medical Center
New York
New York
10032
United States
Memorial Sloan-Kettering Cancer Center
New York
New York
10065
United States
Peter MacCallum Cancer Center
North Melbourne
Victoria
3051
Australia
Centre Georges François Leclerc; Pharmacie des Essais Cliniques
Dijon
21079
France
Centre Leon Berard
Lyon
69008
France
Institut Claudius Regaud; Departement Oncologie Medicale
Toulouse
31059
France
Institut Gustave Roussy
Villejuif
94805
France
Seoul National University Hospital
Seoul
03080
South Korea
Samsung Medical Center
Seoul
06351
South Korea
Asan Medical Center.
Seoul
5505
South Korea
CHUV; Departement d'Oncologie
Lausanne
1011
Switzerland
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
FG002
Atezolizumab + Isatuximab
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
FG003
Atezolizumab + Selicrelumab + Bevacizumab
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
FG004
Atezolizumab + Idasanutlin
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
FG005
Atezolizumab + Regorafenib
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
FG006
Atezolizumab + Regorafenib + AB928
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
FG007
Atezolizumab + LOAd703
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
FG00024 subjects
FG00115 subjects
FG00215 subjects
FG0036 subjects
FG0044 subjects
FG00515 subjects
FG00615 subjects
FG0072 subjects
Received at Least One Dose of Study Treatment
Safety Population
FG00019 subjects
FG00115 subjects
FG00215 subjects
FG0036 subjects
FG0044 subjects
FG00515 subjects
FG00615 subjects
FG0072 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
NOT COMPLETED
FG00024 subjects
FG00115 subjects
FG00215 subjects
FG0036 subjects
FG0044 subjects
FG00515 subjects
FG00615 subjects
FG0072 subjects
Type
Comment
Reasons
Death
FG00018 subjects
FG00115 subjects
FG00215 subjects
FG0034 subjects
FG0044 subjects
FG00511 subjects
FG00612 subjects
FG0071 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Study Terminated By Sponsor
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0003 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
All participants who were randomized in the study, regardless of whether they actually received any study treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Regorafenib (Control)
Participants will receive treatment until unacceptable toxicity or disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
BG001
Atezolizumab + Imprime PGG + Bevacizumab
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
BG002
Atezolizumab + Isatuximab
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
BG003
Atezolizumab + Selicrelumab + Bevacizumab
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
BG004
Atezolizumab + Idasanutlin
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
BG005
Atezolizumab + Regorafenib
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
BG006
Atezolizumab + Regorafenib + AB928
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
BG007
Atezolizumab + LOAd703
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00024
BG00115
BG00215
BG0036
BG0044
BG00515
BG00615
BG0072
BG00896
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Age (year)
Title
Measurements
BG00059.5± 10.3
BG00157.8± 5.9
BG00252.3± 12.0
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00012
BG0017
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0002
BG0014
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0011
BG002
ECOG score
ECOG performance status scale. 0 - Fully active; able to carry on all predisease performance without restriction
1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature
Count of Participants
Participants
Title
Denominators
Categories
0
Title
Measurements
BG00011
BG001
Number of Metastatic Sites at Enrollment
Count of Participants
Participants
Title
Denominators
Categories
1
Title
Measurements
BG0003
BG0011
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Best Confirmed Overall Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
The best confirmed overall response rate (ORR) is defined as the percentage of participants with a complete response or partial response on two consecutive occasions ≥4 weeks apart, as determined by the investigator according to RECIST v1.1. Participants could be classified as "Stable Disease" if the assessment was at least 6 weeks from randomization. Participants were classified as Missing if no post-baseline response assessments were available. Participants were classified as Not Evaluable if all post-baseline response assessments were unevaluable. The differences in ORR between the experimental arms and the corresponding control arm were calculated, along with 95% confidence intervals (CIs), using normal approximation of the binomial distribution. The 95% CIs for ORRs were constructed using the Clopper-Pearson method. The 95% CIs for the difference in rates were constructed using the Wald method with continuity correction.
The efficacy evaluable population included all patients who received at least one dose of each drug for their assigned treatment regimen.
Posted
Number
95% Confidence Interval
Percentage of Participants
From randomization until disease progression or loss of clinical benefit (up to 4 years)
ID
Title
Description
OG000
Regorafenib (Control)
Participants will receive treatment until unacceptable toxicity or disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
OG001
Atezolizumab + Imprime PGG + Bevacizumab
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
OG002
Atezolizumab + Isatuximab
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
OG003
Atezolizumab + Selicrelumab + Bevacizumab
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
OG004
Atezolizumab + Idasanutlin
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
OG005
Atezolizumab + Regorafenib
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
Units
Counts
Participants
OG00019
OG00115
OG00215
OG003
Title
Denominators
Categories
Responders (CR + PR)
Title
Measurements
OG0000(0 to 17.65)
OG0010(0 to 21.80)
OG0020(0 to 21.80)
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
OG005
Difference in Overall Response Rate
6.67
2-Sided
95
-11.92
25.25
The difference in ORR was calculated as the experimental arm (Atezolizumab + Regorafenib) subtracted from the control arm (Regorafenib).
Other
OG000
OG006
Secondary
Progression-Free Survival (PFS) as Determined by Investigator According to RECIST v1.1
Progression-free survival (PFS) after randomization, defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), was determined by the investigator according to RECIST v1.1. For participants who did not have documented disease progression or death, PFS was censored at the day of the last tumor assessment. The Kaplan-Meier method was used to estimate the median for PFS with 95% confidence intervals (CIs) constructed through use of the Brookmeyer and Crowley method.
The efficacy evaluable population included all patients who received at least one dose of each drug for their assigned treatment regimen.
Posted
Median
95% Confidence Interval
Months
From randomization up to the first occurrence of disease or death from any cause (up to 4 years)
ID
Title
Description
OG000
Regorafenib (Control)
Participants will receive treatment until unacceptable toxicity or disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
OG001
Atezolizumab + Imprime PGG + Bevacizumab
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
Secondary
Overall Survival (OS)
Overall survival (OS) is 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 method was used to estimate the median for OS with 95% confidence intervals (CIs) constructed through use of the Brookmeyer and Crowley method.
The efficacy evaluable population included all participants who received at least one dose of each study drug for their assigned treatment regimen.
Posted
Median
95% Confidence Interval
Months
From randomization up to death from any cause (up to 4 years)
ID
Title
Description
OG000
Regorafenib (Control)
Participants will receive treatment until unacceptable toxicity or disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
OG001
Atezolizumab + Imprime PGG + Bevacizumab
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
OG002
Atezolizumab + Isatuximab
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
Secondary
Percentage of Participants Who Were Alive at Landmark Timepoints for Overall Survival (OS)
Overall survival (OS) is 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. OS is shown as the percentage of participants who were event-free at the landmark timepoints of 3, 6, 12, and 18 months.
The efficacy evaluable population included all participants who received at least one dose of each study drug for their assigned treatment regimen. The number analyzed at each landmark timepoint indicates the number of participants who were remaining at risk for an event. The event-free rate was not estimable (NE) for landmark timepoints at which 0 participants were remaining at risk for an an event.
Posted
Number
95% Confidence Interval
Percentage of Participants
3, 6, 12, and 18 months
ID
Title
Description
OG000
Regorafenib (Control)
Participants will receive treatment until unacceptable toxicity or disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
OG001
Atezolizumab + Imprime PGG + Bevacizumab
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
Secondary
Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1
Duration of response is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause.
The duration of response analysis included all participants from the efficacy evaluable population who had a confirmed overall response; only 1 participant in each of the atezolizumab + regorafenib arm and the atezolizumab + regorafenib + AB928 arm had a confirmed response.
Posted
Median
95% Confidence Interval
Months
From the date of first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 4 years)
ID
Title
Description
OG000
Regorafenib (Control)
Participants will receive treatment until unacceptable toxicity or disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
OG001
Atezolizumab + Imprime PGG + Bevacizumab
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
OG002
Atezolizumab + Isatuximab
Secondary
Disease Control Rate (DCR), as Determined by the Investigator Per RECIST v1.1
Disease control rate is defined as the percentage of participants with stable disease for ≥12 weeks or a complete or partial response, as determined by the investigator according to RECIST v1.1.
The efficacy evaluable population included all patients who received at least one dose of each drug for their assigned treatment regimen.
Posted
Number
95% Confidence Interval
Percentage of Participants
From randomization until disease progression or loss of clinical benefit (up to 4 years)
ID
Title
Description
OG000
Regorafenib (Control)
Participants will receive treatment until unacceptable toxicity or disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
OG001
Atezolizumab + Imprime PGG + Bevacizumab
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
OG002
Atezolizumab + Isatuximab
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
Secondary
Percentage of Participants With at Least One Adverse Event (AE)
The incidence, nature, and severity of adverse events (AEs) are reported, with severity determined according to NCI CTCAE v4.0. All AEs were reported until 30 days after the last study dose or until start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest were reported until 135 days (or 180 days for the Atezolizumab + LOAd703 arm only) after the last dose of study treatment.
The safety-evaluable population included all patients who received any amount of dose of any component of study treatment.
Posted
Number
Percentage of Participants
Adverse event data were collected from baseline up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from baseline through survival follow-up (up to 4 years)
ID
Title
Description
OG000
Regorafenib (Control)
Participants will receive treatment until unacceptable toxicity or disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
OG001
Atezolizumab + Imprime PGG + Bevacizumab
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
OG002
Time Frame
Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
Description
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
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
Regorafenib (Control)
Participants will receive treatment until unacceptable toxicity or disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
18
24
5
19
19
19
EG001
Atezolizumab + Imprime PGG + Bevacizumab
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
15
15
1
15
15
15
EG002
Atezolizumab + Isatuximab
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
15
15
5
15
15
15
EG003
Atezolizumab + Selicrelumab + Bevacizumab
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
4
6
3
6
6
6
EG004
Atezolizumab + Idasanutlin
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
4
4
1
4
4
4
EG005
Atezolizumab + Regorafenib
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
11
15
7
15
15
15
EG006
Atezolizumab + Regorafenib + AB928
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
12
15
7
15
15
15
EG007
Atezolizumab + LOAd703
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
1
2
1
2
2
2
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG0030 events0 affected6 at risk
EG004
Leukocytosis
Blood and lymphatic system disorders
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Thrombotic microangiopathy
Blood and lymphatic system disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Asthenia
General disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Perforation
General disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Pyrexia
General disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Biliary obstruction
Hepatobiliary disorders
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Cytokine release syndrome
Immune system disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Biliary tract infection
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Enterocolitis infectious
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Sepsis
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0002 events2 affected19 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Fistula
Musculoskeletal and connective tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Syncope
Nervous system disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Hypertension
Vascular disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA version 25.1
Systematic Assessment
EG0002 events2 affected19 at risk
EG0011 events1 affected15 at risk
EG0023 events3 affected15 at risk
EG0031 events1 affected6 at risk
EG0041 events1 affected4 at risk
EG0053 events3 affected15 at risk
EG0064 events3 affected15 at risk
EG0070 events0 affected2 at risk
Lymphopenia
Blood and lymphatic system disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA version 25.1
Systematic Assessment
EG0002 events2 affected19 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA version 25.1
Systematic Assessment
EG0002 events2 affected19 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Palpitations
Cardiac disorders
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Cerumen impaction
Ear and labyrinth disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Ear haemorrhage
Ear and labyrinth disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA version 25.1
Systematic Assessment
EG0002 events2 affected19 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Vision blurred
Eye disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0005 events5 affected19 at risk
EG0013 events3 affected15 at risk
EG0024 events4 affected15 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0015 events3 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Anal haemorrhage
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0003 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0004 events4 affected19 at risk
EG0013 events3 affected15 at risk
EG0023 events3 affected15 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0009 events6 affected19 at risk
EG0019 events6 affected15 at risk
EG0023 events2 affected15 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0002 events2 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0014 events4 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Frequent bowel movements
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0007 events7 affected19 at risk
EG0015 events3 affected15 at risk
EG0028 events6 affected15 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0002 events2 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Post-tussive vomiting
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Salivary duct inflammation
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0012 events2 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0017 events4 affected15 at risk
EG0024 events3 affected15 at risk
EG003
Asthenia
General disorders
MedDRA version 25.1
Systematic Assessment
EG0002 events2 affected19 at risk
EG0010 events0 affected15 at risk
EG0022 events1 affected15 at risk
EG003
Chest discomfort
General disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Chest pain
General disorders
MedDRA version 25.1
Systematic Assessment
EG0003 events3 affected19 at risk
EG0012 events2 affected15 at risk
EG0023 events2 affected15 at risk
EG003
Chills
General disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0014 events4 affected15 at risk
EG0026 events4 affected15 at risk
EG003
Device related thrombosis
General disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Face oedema
General disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Fatigue
General disorders
MedDRA version 25.1
Systematic Assessment
EG0008 events8 affected19 at risk
EG00111 events7 affected15 at risk
EG00211 events9 affected15 at risk
EG003
General physical health deterioration
General disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Inflammation
General disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Influenza like illness
General disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Injection site reaction
General disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Medical device site erythema
General disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Mucosal inflammation
General disorders
MedDRA version 25.1
Systematic Assessment
EG0002 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0011 events1 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Oedema
General disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Oedema peripheral
General disorders
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Pain
General disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Peripheral swelling
General disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0012 events1 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Pyrexia
General disorders
MedDRA version 25.1
Systematic Assessment
EG0004 events3 affected19 at risk
EG0015 events4 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Swelling face
General disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Systemic inflammatory response syndrome
General disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Hepatic vein thrombosis
Hepatobiliary disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA version 25.1
Systematic Assessment
EG0002 events2 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Cytokine release syndrome
Immune system disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Gingivitis
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Influenza
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Otitis media
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Pneumonia
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Rash pustular
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Sepsis
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Sinusitis
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Soft tissue infection
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Tooth infection
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0023 events3 affected15 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0022 events2 affected15 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Corneal abrasion
Injury, poisoning and procedural complications
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Facial bones fracture
Injury, poisoning and procedural complications
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Gastrointestinal anastomotic leak
Injury, poisoning and procedural complications
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG00116 events8 affected15 at risk
EG00213 events11 affected15 at risk
EG003
Injection related reaction
Injury, poisoning and procedural complications
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Intentional overdose
Injury, poisoning and procedural complications
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Stoma site rash
Injury, poisoning and procedural complications
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA version 25.1
Systematic Assessment
EG0005 events4 affected19 at risk
EG0014 events3 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA version 25.1
Systematic Assessment
EG0004 events3 affected19 at risk
EG0012 events2 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA version 25.1
Systematic Assessment
EG0002 events2 affected19 at risk
EG0012 events2 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA version 25.1
Systematic Assessment
EG0005 events4 affected19 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA version 25.1
Systematic Assessment
EG0003 events2 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Blood creatinine increased
Investigations
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
C-reactive protein increased
Investigations
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Lipase increased
Investigations
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Lymphocyte count increased
Investigations
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Platelet count decreased
Investigations
MedDRA version 25.1
Systematic Assessment
EG0002 events2 affected19 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Weight decreased
Investigations
MedDRA version 25.1
Systematic Assessment
EG0002 events2 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
White blood cell count decreased
Investigations
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA version 25.1
Systematic Assessment
EG0006 events6 affected19 at risk
EG0016 events5 affected15 at risk
EG0024 events4 affected15 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA version 25.1
Systematic Assessment
EG0003 events3 affected19 at risk
EG0010 events0 affected15 at risk
EG0022 events2 affected15 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA version 25.1
Systematic Assessment
EG0002 events2 affected19 at risk
EG0013 events3 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA version 25.1
Systematic Assessment
EG0002 events2 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0011 events1 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0013 events3 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Fracture pain
Musculoskeletal and connective tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Muscle discomfort
Musculoskeletal and connective tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0013 events2 affected15 at risk
EG0022 events2 affected15 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0005 events5 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Tumour fistulisation
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Cerebellar syndrome
Nervous system disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Dizziness
Nervous system disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0022 events2 affected15 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Headache
Nervous system disorders
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Hyperaesthesia
Nervous system disorders
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Myoclonus
Nervous system disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0011 events1 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Sciatica
Nervous system disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Syncope
Nervous system disorders
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Device occlusion
Product Issues
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Agitation
Psychiatric disorders
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Depression
Psychiatric disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA version 25.1
Systematic Assessment
EG0003 events3 affected19 at risk
EG0012 events2 affected15 at risk
EG0022 events2 affected15 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Renal pain
Renal and urinary disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Intermenstrual bleeding
Reproductive system and breast disorders
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Perineal fistula
Reproductive system and breast disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Aphonia
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Systematic Assessment
EG0002 events2 affected19 at risk
EG0014 events3 affected15 at risk
EG0025 events4 affected15 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Systematic Assessment
EG0007 events5 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Systematic Assessment
EG0004 events4 affected19 at risk
EG0012 events2 affected15 at risk
EG0022 events2 affected15 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0022 events2 affected15 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Hair colour changes
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Systematic Assessment
EG00018 events12 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0012 events2 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0012 events1 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0000 events0 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Xeroderma
Skin and subcutaneous tissue disorders
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Hypertension
Vascular disorders
MedDRA version 25.1
Systematic Assessment
EG0007 events6 affected19 at risk
EG0013 events3 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Vena cava thrombosis
Vascular disorders
MedDRA version 25.1
Systematic Assessment
EG0001 events1 affected19 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
This study is not designed to make explicit power and Type I error considerations for a hypothesis test. Instead, this study is designed to obtain preliminary efficacy, safety, and PK data. No formal statistical hypothesis testing was performed in this study. Due to the limited sample size, the results need to be interpreted with caution. For the Atezo+Idasa and Atezo+LOAd703 groups, no meaningful conclusion could be drawn because these experimental arms have been terminated prematurely.
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 will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
OG007
Atezolizumab + LOAd703
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
6
OG0044
OG00515
OG00615
OG0072
0
(0 to 45.93)
OG0040(0 to 60.24)
OG0056.7(0.17 to 31.95)
OG0066.7(0.17 to 31.95)
OG0070(0 to 84.19)
Complete Response (CR)
Title
Measurements
OG0000(0 to 17.65)
OG0010(0 to 21.80)
OG0020(0 to 21.80)
OG0030(0 to 45.93)
OG0040(0 to 60.24)
OG0050(0 to 21.80)
OG0060(0 to 21.80)
OG0070(0 to 84.19)
Partial Response (PR)
Title
Measurements
OG0000(0 to 17.65)
OG0010(0 to 21.80)
OG0020(0 to 21.80)
OG0030(0 to 45.93)
OG0040(0 to 60.24)
OG0056.7(0.17 to 31.95)
OG0066.7(0.17 to 31.95)
OG0070(0 to 84.19)
Stable Disease (SD)
Title
Measurements
OG00063.2(38.36 to 83.71)
OG00133.3(11.82 to 61.62)
OG00220.0(4.33 to 48.09)
OG00350(11.81 to 88.19)
OG0040(0 to 60.24)
OG00533.3(11.82 to 61.62)
OG00653.3(26.59 to 78.73)
OG0070(0 to 84.19)
Progressive Disease (PD)
Title
Measurements
OG00026.3(9.15 to 51.20)
OG00166.7(38.38 to 88.18)
OG00266.7(38.38 to 88.18)
OG00333.3(4.33 to 77.72)
OG004100(39.76 to 100)
OG00546.7(21.27 to 73.41)
OG00626.7(7.79 to 55.10)
OG007100(15.81 to 100)
Not Evaluable
Title
Measurements
OG0000(NA to NA)The 95% CI was only calculated for responses per RECIST, not for participants who were not evaluable or missing.
OG0010(NA to NA)The 95% CI was only calculated for responses per RECIST, not for participants who were not evaluable or missing.
OG00213.3(NA to NA)The 95% CI was only calculated for responses per RECIST, not for participants who were not evaluable or missing.
OG0030(NA to NA)The 95% CI was only calculated for responses per RECIST, not for participants who were not evaluable or missing.
OG0040(NA to NA)The 95% CI was only calculated for responses per RECIST, not for participants who were not evaluable or missing.
OG0050(NA to NA)The 95% CI was only calculated for responses per RECIST, not for participants who were not evaluable or missing.
OG00613.3(NA to NA)The 95% CI was only calculated for responses per RECIST, not for participants who were not evaluable or missing.
OG0070(NA to NA)The 95% CI was only calculated for responses per RECIST, not for participants who were not evaluable or missing.
Missing
Title
Measurements
OG00010.5(NA to NA)The 95% CI was only calculated for responses per RECIST, not for participants who were not evaluable or missing.
OG0010(NA to NA)The 95% CI was only calculated for responses per RECIST, not for participants who were not evaluable or missing.
OG0020(NA to NA)The 95% CI was only calculated for responses per RECIST, not for participants who were not evaluable or missing.
OG00316.7(NA to NA)The 95% CI was only calculated for responses per RECIST, not for participants who were not evaluable or missing.
OG0040(NA to NA)The 95% CI was only calculated for responses per RECIST, not for participants who were not evaluable or missing.
OG00513.3(NA to NA)The 95% CI was only calculated for responses per RECIST, not for participants who were not evaluable or missing.
OG0060(NA to NA)The 95% CI was only calculated for responses per RECIST, not for participants who were not evaluable or missing.
OG0070(NA to NA)The 95% CI was only calculated for responses per RECIST, not for participants who were not evaluable or missing.
Difference in Overall Response Rate
6.67
2-Sided
95
-11.92
25.25
The difference in ORR was calculated as the experimental arm (Atezolizumab + Regorafenib + AB928) subtracted from the control arm (Regorafenib).
Other
OG002
Atezolizumab + Isatuximab
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
OG003
Atezolizumab + Selicrelumab + Bevacizumab
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
OG004
Atezolizumab + Idasanutlin
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
OG005
Atezolizumab + Regorafenib
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
OG006
Atezolizumab + Regorafenib + AB928
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
OG007
Atezolizumab + LOAd703
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
Units
Counts
Participants
OG00019
OG00115
OG00215
OG0036
OG0044
OG00515
OG00615
OG0072
Title
Denominators
Categories
Title
Measurements
OG0002.83(2.20 to 3.02)
OG0011.51(1.38 to 2.79)
OG0021.41(1.41 to 1.77)
OG0034.21(1.68 to NA)The upper limit of the 95% CI was not estimable because too few events had occurred.
OG0041.26(0.82 to NA)The upper limit of the 95% CI was not estimable because too few events had occurred.
OG0051.81(1.38 to 2.96)
OG0064.60(2.60 to 5.78)
OG0071.58(1.51 to NA)The upper limit of the 95% CI was not estimable because too few events had occurred.
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)
1.35
2-Sided
95
0.67
2.73
Other
OG000
OG002
Hazard Ratio (HR)
2.30
2-Sided
95
1.08
4.88
Other
OG000
OG003
Hazard Ratio (HR)
0.79
2-Sided
95
0.29
2.18
Other
OG000
OG004
Hazard Ratio (HR)
2.00
2-Sided
95
0.64
6.24
Other
OG000
OG005
Hazard Ratio (HR)
1.74
2-Sided
95
0.83
3.63
Other
OG000
OG006
Hazard Ratio (HR)
0.80
2-Sided
95
0.39
1.63
Other
OG000
OG007
Hazard Ratio (HR)
5.64
2-Sided
95
0.94
33.82
Other
OG003
Atezolizumab + Selicrelumab + Bevacizumab
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
OG004
Atezolizumab + Idasanutlin
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
OG005
Atezolizumab + Regorafenib
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
OG006
Atezolizumab + Regorafenib + AB928
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
OG007
Atezolizumab + LOAd703
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
Units
Counts
Participants
OG00019
OG00115
OG00215
OG0036
OG0044
OG00515
OG00615
OG0072
Title
Denominators
Categories
Title
Measurements
OG00010.15(4.40 to 12.29)
OG0015.72(4.37 to 10.51)
OG0025.13(3.12 to 7.75)
OG00314.36(3.22 to NA)The upper limit of the 95% CI was not estimable because too few events had occurred.
OG0045.93(1.61 to NA)The upper limit of the 95% CI was not estimable because too few events had occurred.
OG00511.01(5.29 to 16.66)
OG0068.67(6.60 to 14.62)
OG0074.07(NA to NA)The lower and upper limits of the 95% CI were not estimable because too few events had occurred.
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
Atezolizumab + Imprime PGG + Bevacizumab vs. Regorafenib (Control) Hazard Ratio for OS
Hazard Ratio (HR)
1.44
2-Sided
95
0.71
2.93
Other
Kaplan-Meier
OG000
OG002
Atezolizumab + Isatuximab vs. Regorafenib (Control) Hazard Ratio for OS
Hazard Ratio (HR)
1.38
2-Sided
95
0.68
2.81
Other
Kaplan-Meier
OG000
OG003
Atezolizumab + Selicrelumab + Bevacizumab vs. Regorafenib (Control) Hazard Ratio for OS
Hazard Ratio (HR)
0.90
2-Sided
95
0.30
2.72
Other
Kaplan-Meier
OG000
OG004
Atezolizumab + Idasanutlin vs. Regorafenib (Control) Hazard Ratio for OS
Hazard Ratio (HR)
1.27
2-Sided
95
0.42
3.84
Other
Kaplan-Meier
OG000
OG005
Atezolizumab + Regorafenib vs. Regorafenib (Control) Hazard Ratio for OS
Hazard Ratio (HR)
0.86
2-Sided
95
0.39
1.88
Other
Kaplan-Meier
OG000
OG006
Atezolizumab + Regorafenib + AB928 vs. Regorafenib (Control) Hazard Ratio for OS
Hazard Ratio (HR)
0.92
2-Sided
95
0.43
1.96
Other
Kaplan-Meier
OG000
OG007
Atezolizumab + LOAd703 vs. Regorafenib (Control) Hazard Ratio for OS
Hazard Ratio (HR)
2.88
2-Sided
95
0.33
24.85
Other
Kaplan-Meier
OG002
Atezolizumab + Isatuximab
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
OG003
Atezolizumab + Selicrelumab + Bevacizumab
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
OG004
Atezolizumab + Idasanutlin
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
OG005
Atezolizumab + Regorafenib
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
OG006
Atezolizumab + Regorafenib + AB928
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
OG007
Atezolizumab + LOAd703
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
Units
Counts
Participants
OG00019
OG00115
OG00215
OG0036
OG0044
OG00515
OG00615
OG0072
Title
Denominators
Categories
3 Months
ParticipantsOG00016
ParticipantsOG00115
ParticipantsOG00211
ParticipantsOG0035
ParticipantsOG0043
ParticipantsOG00511
ParticipantsOG00613
ParticipantsOG0071
Title
Measurements
OG00084.21(67.81 to 100)
OG001100.00(100.00 to 100.00)
OG00273.33(50.95 to 95.71)
OG003
6 Months
ParticipantsOG00011
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG0033
12 Months
ParticipantsOG0006
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0032
18 Months
ParticipantsOG0003
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0031
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 OS event-free rate at 3 months for the Atezolizumab + Imprime PGG + Bevacizumab vs. Regorafenib (Control) arms
Difference in OS Event-Free Rate
15.79
2-Sided
95
-0.61
32.19
Other
OG000
OG001
Difference in OS event-free rate at 6 months for the Atezolizumab + Imprime PGG + Bevacizumab vs. Regorafenib (Control) arms
Difference in OS Event-Free Rate
-16.49
2-Sided
95
-49.78
16.79
Other
OG000
OG001
Difference in OS event-free rate at 12 months for the Atezolizumab + Imprime PGG + Bevacizumab vs. Regorafenib (Control) arms
Difference in OS Event-Free Rate
-14.45
2-Sided
95
-44.37
15.47
Other
OG000
OG001
Difference in OS event-free rate at 18 months for the Atezolizumab + Imprime PGG + Bevacizumab vs. Regorafenib (Control) arms
Difference in OS Event-Free Rate
-10.56
2-Sided
95
-32.25
11.14
Other
OG000
OG002
Difference in OS event-free rate at 3 months for the Atezolizumab + Isatuximab vs. Regorafenib (Control) arms
Difference in OS Event-Free Rate
-10.88
2-Sided
95
-38.62
16.87
Other
OG000
OG002
Difference in OS event-free rate at 6 months for the Atezolizumab + Isatuximab vs. Regorafenib (Control) arms
Difference in OS Event-Free Rate
-23.16
2-Sided
95
-56.10
9.78
Other
OG000
OG002
Difference in OS event-free rate at 12 months for the Atezolizumab + Isatuximab vs. Regorafenib (Control) arms
Difference in OS Event-Free Rate
-7.78
2-Sided
95
-39.19
23.62
Other
OG000
OG002
Difference in OS event-free rate at 18 months for the Atezolizumab + Isatuximab vs. Regorafenib (Control) arms
Difference in OS Event-Free Rate
2.78
2-Sided
95
-24.08
29.63
Other
OG000
OG003
Difference in OS event-free rate at 3 months for the Atezolizumab + Selicrelumab + Bevacizumab vs. Regorafenib (Control) arms
Difference in OS Event-Free Rate
15.79
2-Sided
95
-0.61
32.19
Other
OG000
OG003
Difference in OS event-free rate at 6 months for the Atezolizumab + Selicrelumab + Bevacizumab vs. Regorafenib (Control) arms
Difference in OS Event-Free Rate
16.84
2-Sided
95
-24.39
58.07
Other
OG000
OG003
Difference in OS event-free rate at 12 months for the Atezolizumab + Selicrelumab + Bevacizumab vs. Regorafenib (Control) arms
Difference in OS Event-Free Rate
18.88
2-Sided
95
-34.53
72.30
Other
OG000
OG003
Difference in OS event-free rate at 18 months for the Atezolizumab + Selicrelumab + Bevacizumab vs. Regorafenib (Control) arms
Difference in OS Event-Free Rate
9.44
2-Sided
95
-38.19
57.08
Other
OG000
OG004
Difference in OS event-free rate at 3 months for the Atezolizumab + Idasanutlin vs. Regorafenib (Control) arms
Difference in OS Event-Free Rate
-9.21
2-Sided
95
-54.70
36.28
Other
OG000
OG004
Difference in OS event-free rate at 6 months for the Atezolizumab + Idasanutlin vs. Regorafenib (Control) arms
Difference in OS Event-Free Rate
-13.16
2-Sided
95
-66.74
40.43
Other
OG000
OG004
Difference in OS event-free rate at 12 months for the Atezolizumab + Idasanutlin vs. Regorafenib (Control) arms
Difference in OS Event-Free Rate
-9.45
2-Sided
95
-57.26
38.36
Other
OG000
OG004
Difference in OS event-free rate at 18 months for the Atezolizumab + Idasanutlin vs. Regorafenib (Control) arms
Difference in OS Event-Free Rate
7.78
2-Sided
95
-38.18
53.73
Other
OG000
OG005
Difference in OS event-free rate at 3 months for the Atezolizumab + Regorafenib vs. Regorafenib (Control) arms
Difference in OS Event-Free Rate
-5.24
2-Sided
95
-32.03
21.56
Other
OG000
OG005
Difference in OS event-free rate at 6 months for the Atezolizumab + Regorafenib vs. Regorafenib (Control) arms
Difference in OS Event-Free Rate
8.64
2-Sided
95
-23.33
40.60
Other
OG000
OG005
Difference in OS event-free rate at 12 months for the Atezolizumab + Regorafenib vs. Regorafenib (Control) arms
Difference in OS Event-Free Rate
5.44
2-Sided
95
-29.19
40.06
Other
OG000
OG005
Difference in OS event-free rate at 18 months for the Atezolizumab + Regorafenib vs. Regorafenib (Control) arms
Difference in OS Event-Free Rate
6.71
2-Sided
95
-22.64
36.06
Other
OG000
OG006
Difference in OS event-free rate at 3 months for the Atezolizumab + Regorafenib + AB928 vs. Regorafenib (Control) arms
Difference in OS Event-Free Rate
2.46
2-Sided
95
-21.31
26.22
Other
OG000
OG006
Difference in OS event-free rate at 6 months for the Atezolizumab + Regorafenib + AB928 vs. Regorafenib (Control) arms
Difference in OS Event-Free Rate
10.18
2-Sided
95
-20.99
41.34
Other
OG000
OG006
Difference in OS event-free rate at 12 months for the Atezolizumab + Regorafenib + AB928 vs. Regorafenib (Control) arms
Difference in OS Event-Free Rate
-1.12
2-Sided
95
-33.59
31.36
Other
OG000
OG006
Difference in OS event-free rate at 18 months for the Atezolizumab + Regorafenib + AB928 vs. Regorafenib (Control) arms
Difference in OS Event-Free Rate
9.44
2-Sided
95
-19.06
37.94
Other
OG000
OG007
Difference in OS event-free rate at 3 months for the Atezolizumab +LOAd703 vs. Regorafenib (Control) arms
Difference in OS Event-Free Rate
15.79
2-Sided
95
-0.61
32.19
Other
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
OG003
Atezolizumab + Selicrelumab + Bevacizumab
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
OG004
Atezolizumab + Idasanutlin
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
OG005
Atezolizumab + Regorafenib
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
OG006
Atezolizumab + Regorafenib + AB928
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
OG007
Atezolizumab + LOAd703
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
OG0061
OG0070
Title
Denominators
Categories
Title
Measurements
OG0053.12(NA to NA)Only 1 participant had a confirmed response; 95% CI could not be calculated.
OG0065.75(NA to NA)Only 1 participant had a confirmed response; 95% CI could not be calculated.
OG003
Atezolizumab + Selicrelumab + Bevacizumab
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
OG004
Atezolizumab + Idasanutlin
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
OG005
Atezolizumab + Regorafenib
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
OG006
Atezolizumab + Regorafenib + AB928
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
OG007
Atezolizumab + LOAd703
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
Units
Counts
Participants
OG00019
OG00115
OG00215
OG0036
OG0044
OG00515
OG00615
OG0072
Title
Denominators
Categories
Title
Measurements
OG00015.8(3.38 to 39.58)
OG00113.3(1.66 to 40.46)
OG0026.7(0.17 to 31.95)
OG00333.3(4.33 to 77.72)
OG0040(0.00 to 60.24)
OG00513.3(1.66 to 40.46)
OG00640.0(16.34 to 67.71)
OG0070(0.00 to 84.19)
Atezolizumab + Isatuximab
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
OG003
Atezolizumab + Selicrelumab + Bevacizumab
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
OG004
Atezolizumab + Idasanutlin
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
OG005
Atezolizumab + Regorafenib
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
OG006
Atezolizumab + Regorafenib + AB928
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
OG007
Atezolizumab + LOAd703
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
Units
Counts
Participants
OG00019
OG00115
OG00215
OG0036
OG0044
OG00515
OG00615
OG0072
Title
Denominators
Categories
Adverse Event (AE)
Title
Measurements
OG000100
OG001100
OG002100
OG003100
OG004100
OG005100
OG006100
OG007100
Death
Title
Measurements
OG00089.5
OG001100
OG002100
OG003
Withdrawn from Stage due to an AE
Title
Measurements
OG00015.8
OG0016.7
OG0020
OG003
AE with a Fatal Outcome
Title
Measurements
OG00010.5
OG0010
OG0020
OG003
Serious AE (SAE)
Title
Measurements
OG00026.3
OG0016.7
OG00233.3
OG003
SAE Leading to Withdrawal from any Treatment
Title
Measurements
OG00021.1
OG0016.7
OG0020
OG003
SAE Leading to Dose Modification/Interruption
Title
Measurements
OG0005.3
OG0010
OG0026.7
OG003
Related SAE
Title
Measurements
OG0005.3
OG0016.7
OG0020
OG003
AE Leading to Withdrawal from any Treatment
Title
Measurements
OG00026.3
OG0016.7
OG0020
OG003
AE Leading to Dose Modification/Interruption
Title
Measurements
OG00063.2
OG00140.0
OG00213.3
OG003
Related AE
Title
Measurements
OG00094.7
OG00186.7
OG00286.7
OG003
Related AE Leading to Withdrawal from any Treatment
Title
Measurements
OG00010.5
OG0016.7
OG0020
OG003
Related AE Leading to Dose Modification/Interruption