A Study of Multiple Immunotherapy-Based Treatment Combina... | NCT03193190 | Trialant
NCT03193190
Sponsor
Hoffmann-La Roche
Status
Completed
Last Update Posted
Nov 21, 2025Actual
Enrollment
341Actual
Phase
Phase 1Phase 2
Conditions
Pancreatic Adenocarcinoma
Interventions
Nab-Paclitaxel
Gemcitabine
Oxaliplatin
Leucovorin
Fluorouracil
Atezolizumab
Cobimetinib
PEGPH20
BL-8040
Selicrelumab
Bevacizumab
RO6874281
AB928
Tiragolumab
Tocilizumab
Countries
United States
Germany
Japan
South Korea
Spain
Protocol Section
Identification Module
NCT ID
NCT03193190
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
WO39608
Secondary IDs
ID
Type
Description
Link
2016-004126-42
EudraCT Number
Brief Title
A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer)
Official Title
A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer)
Acronym
Not provided
Organization
Hoffmann-La RocheINDUSTRY
Status Module
Record Verification Date
Nov 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 5, 2017Actual
Primary Completion Date
Feb 27, 2025Actual
Completion Date
Feb 27, 2025Actual
First Submitted Date
Jun 9, 2017
First Submission Date that Met QC Criteria
Jun 16, 2017
First Posted Date
Jun 20, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Nov 10, 2025
Results First Submitted that Met QC Criteria
Nov 10, 2025
Results First Posted Date
Nov 21, 2025Actual
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 10, 2025
Last Update Posted Date
Nov 21, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Hoffmann-La RocheINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
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 participants with metastatic Pancreatic Ductal Adenocarcinoma (PDAC).
Two cohorts will be enrolled in parallel in this study: Cohort 1 will consist of patients who have received no prior systemic therapy for metastatic PDAC, and Cohort 2 will consist of patients who have received one line of prior systemic therapy for PDAC. In each cohort, eligible patients will be assigned to one of several treatment arms.
Detailed Description
Not provided
Conditions Module
Conditions
Pancreatic Adenocarcinoma
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
341Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1: Control (Nab-Paclitaxel and Gemcitabine)
Active Comparator
Cohort 1: Participants will receive Nab-Paclitaxel 125 mg/m^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle; and Gemcitabine 1000 mg/m^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle.
Participants in the Cohort 1 control arm who experience disease progression will be given the option of enrolling into Cohort 2 (if open for enrollment), provided they meet eligibility criteria.
Cohort 1: Participants will receive Atezolizumab 840 mg IV infusion on Days 1 and 15 of each 28 day cycle; Nab-paclitaxel 125 mg/m^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle; Gemcitabine 1000 mg/m^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle; and Selicrelumab 16 mg subcutaneous injection on Day 1 of Cycles 1-4 and every third cycle thereafter (i.e. Cycles 7, 10, 13 etc.) of each 28-day cycle.
Cohort 1: Participants will receive Atezolizumab 840 mg IV infusion on Days 1 and 15 of each 28 day cycle; Bevacizumab 10 mg/kg IV infusion on Days 1 and 15 of each 28 day cycle; Nab-paclitaxel 125 mg/m^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle; Gemcitabine 1000 mg/m^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle.
Drug: Nab-Paclitaxel
Drug: Gemcitabine
Drug: Atezolizumab
Drug: Bevacizumab
Cohort 1: Atezolizumab + Chemotherapy + AB928
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Nab-Paclitaxel
Drug
Nab-Paclitaxel will be administered as per the schedule specified in the respective arm.
Stage 1: Percentage of Participants With Objective Response (OR), as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
OR was defined as a complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart during Stage 1 as determined by the investigator using RECIST v.1.1. Objective response rate (ORR) was defined as the percentage of participants with OR. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD. 95% confidence intervals (CI) for rates were constructed using Clopper-Pearson method. Percentages have been rounded off.
Up to 33.3 months
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma
For patients in Cohort 1: no prior systemic treatment for PDAC
For patients in Cohort 2: disease progression during administration of either 5-FU- or gemcitabine-based first-line chemotherapy
Life expectancy greater than or equal to 3 months
Availability of a representative tumor specimen that is suitable for determination of programmed death-ligand 1 (PD-L1) and/or additional biomarker status via central testing
Measurable disease (at least one target lesion) according to RECIST v1.1
Adequate hematologic and end-organ function test results
Tumor accessible for biopsy
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating eggs, as outlined for each specific treatment arm
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as outlined for each specific treatment arm
Exclusion Criteria:
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage procedure (i.e., more than one time per month)
Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
History of leptomeningeal disease
Active or history of autoimmune disease or immune deficiency
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
Positive human immunodeficiency (HIV) test at screening or at any time prior to screening
Active hepatitis B or C virus infection or active tuberculosis
Severe infection within 4 weeks prior to initiation of study treatment
Prior allogeneic stem cell or solid organ transplantation
History of malignancy other than pancreatic carcinoma within 2 years prior to screening, with the exception of those with a negligible risk of metastasis or death
Ko AH, Kim KP, Siveke JT, Lopez CD, Lacy J, O'Reilly EM, Macarulla T, Manji GA, Lee J, Ajani J, Alsina Maqueda M, Rha SY, Lau J, Al-Sakaff N, Allen S, Lu D, Shemesh CS, Gan X, Cha E, Oh DY. Atezolizumab Plus PEGPH20 Versus Chemotherapy in Advanced Pancreatic Ductal Adenocarcinoma and Gastric Cancer: MORPHEUS Phase Ib/II Umbrella Randomized Study Platform. Oncologist. 2023 Jun 2;28(6):553-e472. doi: 10.1093/oncolo/oyad022.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Eligible participants from both cohorts were assigned to one of several treatment arms in Stage 1. Cohort 2 participants with disease progression (PD), loss of clinical benefit, or unacceptable toxicity in Stage 1 were eligible for a different treatment combination in Stage 2. The study is considered "Completed" because all the pre-planned study activities and analyses have been performed.
Recruitment Details
A total of 341 participants with metastatic pancreatic ductal adenocarcinoma (PDAC) took part in the study from 05 Jul 2017 to 27 Feb 2025. The study included participants in 2 cohorts: Cohort 1: received no prior systemic therapy for metastatic PDAC & Cohort 2: received 1 prior line of systemic therapy for PDAC. Multiple combination therapies were compared against common control(s) in Cohorts 1 and 2.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Stage 1 Cohort 1 : Control (Chemotherapy: Nab-Paclitaxel and Gemcitabine)
Participants received nab-paclitaxel, 125 milligrams/meter square (mg/m^2), intravenous (IV) infusion and gemcitabine ,1000 mg/m^2, IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle = 28 days).
FG001
Periods
Title
Milestones
Reasons Not Completed
Stage 1
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
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
Oct 4, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Experimental
Cohort 1: Participant will receive AB928 150 mg orally once daily on Days 1 to 28 of each 28 day cycle; Atezolizumab 840 mg IV infusion on Days 1 and 15 of each 28 day cycle; Nab-paclitaxel 125 mg/m^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle; Gemcitabine 1000 mg/m^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle.
Cohort 1: Participants will receive Atezolizumab 840 mg IV infusion on Days 1 and 15 of each 28 day cycle; Tiragolumab 420 mg IV infusion on Days 1 and 15 of each 28 day cycle; Nab-paclitaxel 125 mg/m^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle; Gemcitabine 1000 mg/m^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle.
Drug: Nab-Paclitaxel
Drug: Gemcitabine
Drug: Atezolizumab
Drug: Tiragolumab
Cohort 2: Atezolizumab + Cobimetinib
Experimental
Cohort 2: Participants will receive Cobimetinib 60 milligrams (mg) once daily orally on Days 1-21 of each 28-day cycle; and Atezolizumab 840 mg IV infusion on Days 1 and 15 of each 28-day cycle.
Participants who progressed on treatment may have the option of receiving Atezolizumab + RO6874281 treatment, provided they meet the eligibility criteria and the arm is open for enrollment.
Drug: Atezolizumab
Drug: Cobimetinib
Cohort 2: Atezolizumab + PEGPH20
Experimental
Cohort 2: Participants will receive PEGPH20 3 micrograms per kilogram (mcg/kg) IV infusion on Days 1, 8 and 15 of each 21-day cycle; and Atezolizumab 1200 mg IV infusion on Day 1 of each 21-day cycle.
Participants who progressed on treatment, may have the option of receiving Atezolizumab + Cobimetinib or Atezolizumab + RO6874281 treatment, provided they meet the eligibility criteria and the arms are open for enrollment.
Drug: Atezolizumab
Drug: PEGPH20
Cohort 2: Atezolizumab + BL-8040
Experimental
Cohort 2: Participants will receive BL-8040 1.25 milligrams per kilogram (mg/kg) subcutaneously (SC) on Days 1-5 of the first week, followed by combination treatment consisting of BL-8040 1.25 mg/kg SC three times a week on non-consecutive days and Atezolizumab 1200 mg IV infusion on Day 1 of each 21-day cycle.
Participants who progressed on treatment may have the option of receiving Atezolizumab + Cobimetinib or Atezolizumab + RO6874281 treatment, provided they meet the eligibility criteria and the arms are open for enrollment.
Drug: Atezolizumab
Drug: BL-8040
Cohort 2: Atezolizumab + RO6874281 every 2 weeks
Experimental
Cohort 2: Participants will receive Atezolizumab 840 mg IV infusion on days 1 and 15 of each 28 day cycle; RO6874281 will be administered 10 mg by IV infusion on day 1 and 15 mg on days 8, 15, and 22 for cycle 1 (28 day cycle). RO6874281 will be administered 15 mg by IV infusion on days 1 and 15 of each subsequent 28 day cycle.
Participants who progressed on treatment may have the option of receiving Atezolizumab + Cobimetinib, provided they meet the eligibility criteria and the arm is open for enrollment.
Drug: Atezolizumab
Drug: RO6874281
Cohort 2: Atezolizumab + RO6874281 every 3 weeks
Experimental
Cohort 2: Participants will receive Atezolizumab 1200 mg IV infusion on Day 1 of each 21 day cycle; and RO6874281 10 mg by IV infusion on day 1 of each 21 day cycle.
Participants who progressed on treatment may have the option of receiving Atezolizumab + Cobimetinib, provided they meet the eligibility criteria and the arm is open for enrollment.
Drug: Atezolizumab
Drug: RO6874281
Cohort 2: Control (Nab-Paclitaxel and Gemcitabine or mFOLFOX6)
Active Comparator
Cohort 2: Participants who progressed on a prior fluoropyrimidine-based regimen will receive Nab-paclitaxel 125 mg/m^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle; and Gemcitabine 1000 mg/m^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle.
Participants who progressed on a prior gemcitabine-based regimen will receive 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6). Participants will receive Oxaliplatin 85 mg/m^2 IV on Days 1 and 15 of each 28 day cycle; Leucovorin 400 mg/m^2 IV on Days 1 and 15 of each 28 day cycle; Fluorouracil 400 mg/m^2 IV push on Days 1 and 15 of each 28 day cycle; and Fluorouracil 2400 mg/m^2 IV continuous infusion over 46 hours on Days 1 and 2 and on Days 15 and 16 of each 28 day cycle.
Participants who progressed on treatment, may have the option of receiving Atezolizumab + Cobimetinib or Atezolizumab + RO6874281 treatment, provided they meet the eligibility criteria and the arms are open for enrollment.
Cohort 1: Participants will receive Tocilizumab 8 mg/kg IV infusion on Day 1 of each 28 day cycle; Atezolizumab 1680 mg IV infusion on Day 1 of each 28 day cycle; Nab-paclitaxel 125 mg/m^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle; and Gemcitabine 1000 mg/m^2 IV infusion on Days 1, 8, and 15 of each 28 day cycle.
Stage 1: Progression-Free Survival (PFS), as Determined by Investigator According to RECIST v1.1
PFS was defined as the time from study treatment initiation to the first occurrence of documented PD, as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Kaplan-Meier (K-M) method was used to estimate PFS.
Up to 33.3 months
Stage 1: Overall Survival (OS), as Determined by Investigator According to RECIST v1.1
OS was defined as the time from randomization to death from any cause. K-M method was used to estimate OS.
Up to 33.3 months
Stage 1: OS Rate at Month 6
OS was defined as the time from randomization to death from any cause. OS rate at 6 months was defined as the percentage of participants who did not experience death from any cause at 6 months from randomization. K-M method was used to estimate OS. Percentages have been rounded off.
Month 6
Stage 1: Duration of Response (DOR), as Determined by Investigator According to RECIST v1.1
DOR was defined as time from first occurrence of a documented OR until the time of documented PD or death from any cause, whichever occurs first as determined by investigator assessment using RECIST v1.1. DOR was calculated for participants who had a best confirmed OR of CR/PR. CR=the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR=at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. PD=at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. K-M method was used to estimate DOR.
Up to 33.3 months
Stage 1: Percentage of Participants With Disease Control (DC), as Determined by Investigator According to RECIST v1.1
DC was defined as stable disease (SD) for ≥ 12 weeks or a CR or PR, as determined by the investigator according to RECIST v1.1 Disease control rate (DCR) was defined as the percentage of participants with DC. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Percentages have been rounded off.
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m^2 and gemcitabine, 1000 mg/m^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle. Participants also received selicrelumab, 16 mg, subcutaneous (SC) injection on Day 1 of Cycles 1-4 and every third cycle thereafter (i.e. Cycles 7, 10, 13 etc.) of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants received atezolizumab, 840 mg, and bevacizumab, 10 milligrams/kilograms (mg/kg), IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel 125 mg/m^2, and gemcitabine, 1000 mg/m^2 also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants received AB928, 150 mg, orally, once daily (QD) on Days 1 to 28 of each cycle; atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle and nab-paclitaxel, 125 mg/m^2, and gemcitabine, 1000 mg/m^2, also administered as IV infusion, on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants received atezolizumab, 840 mg and tiragolumab, 420 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m^2 and gemcitabine, 1000 mg/m^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants received atezolizumab, 1680 mg and tocilizumab, 8 mg/kg, IV infusion on Days 1 of each cycle along with nab-paclitaxel, 125 mg/m^2 and gemcitabine, 1000 mg/m^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants who progressed on a prior gemcitabine-based regimen received mFOLFOX6 which is oxaliplatin, 85 mg/m^2 and leucovorin, 400 mg/m^2 as IV infusion, and 5-fluorouracil, 400 mg/m^2, IV push on Days 1 and 15 of each cycle along with 5-fluorouracil, 2400 mg/m^2, IV continuous infusion on Days 1, 2, 15 and 16 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
FG007
Stage 1 Cohort 2: Control (Nab-Paclitaxel and Gemcitabine)
Participants who progressed on a prior fluoropyrimidine-based regimen received nab-paclitaxel, 125 mg/m^2 and gemcitabine, 1000 mg/m^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
FG008
Stage 1 Cohort 2: Atezolizumab + BL-8040
Participants received BL-8040, 1.25 mg/kg, SC injection on Days 1-5 of the first week, as priming treatment, and thereafter three times a week (Days 1, 3, 5, 8, 10, 12, 15, 17, and 19) along with atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
FG009
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and cobimetinib 60 mg, orally, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
FG010
Stage 1 Cohort 2: Atezolizumab + PEGPH20
Participants received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and PEGPH20, 3 micrograms per kilogram (µg/kg), IV infusion on Days 1, 8 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
Participants received atezolizumab, 1200 mg, IV infusion and RO6874281, 10 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and RO6874281, 10 mg, IV infusion on Day 1 and 15 mg on Days 8, 15, and 22 of Cycle 1 and thereafter 15 mg on Days 1 and 15 of subsequent cycles until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
FG013
Stage 2 Cohort 2: Atezolizumab + Cobimetinib
Participants in Cohort 2 control and experimental arms (other than atezolizumab + cobimetinib) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and met the eligibility criteria to enroll in Stage 2 received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and cobimetinib, 60 mg, orally, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
FG014
Stage 2 Cohort 2: Atezolizumab + RO6874281 Q3W
Participants in cohort 2 control and experimental arms (other than atezolizumab + RO6874281 Q3W) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 received atezolizumab, 1200 mg, IV infusion and RO6874281, 10 mg, as IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
FG015
Stage 2 Cohort 2: Atezolizumab + RO6874281 Q2W
Participants in cohort 2 control and experimental arms (other than atezolizumab + RO6874281 Q2W) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and RO6874281, 10 mg, IV infusion on Day 1 and 15 mg on Days 8, 15, and 22 of Cycle 1 and thereafter 15 mg on Days 1 and 15 of subsequent cycles until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
FG00035 subjects
FG0019 subjects
FG00225 subjects
FG00316 subjects
FG00442 subjects
FG00531 subjects
FG00625 subjects
FG00725 subjects
FG00816 subjects
FG00915 subjects
FG01071 subjects
FG01116 subjects
FG01215 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
Safety Population
Safety population included all participants who received any amount of study treatment.
FG00032 subjects
FG0019 subjects
FG00225 subjects
FG00315 subjects
FG00441 subjects
FG00530 subjects
FG00623 subjects
FG00723 subjects
FG00815 subjects
FG00914 subjects
FG01066 subjects
FG01115 subjects
FG01214 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
NOT COMPLETED
FG00035 subjects
FG0019 subjects
FG00225 subjects
FG00316 subjects
FG00442 subjects
FG00531 subjects
FG00625 subjects
FG00725 subjects
FG00816 subjects
FG00915 subjects
FG01071 subjects
FG01116 subjects
FG01215 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
Type
Comment
Reasons
Arm Terminated by Sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0052 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
Death
FG00022 subjects
FG0018 subjects
FG00223 subjects
FG00314 subjects
FG004
Lost to Follow-up
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Reason not Specified
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Progressive Disease
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Study Terminated By Sponsor
FG0003 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0006 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Stage 2
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG01315 subjects
FG0146 subjects
FG0151 subjects
Safety Population
Safety population included all participants who received any amount of study treatment.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Intent to treat (ITT) population included all randomized participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Stage 1 Cohort 1 : Control (Chemotherapy: Nab-Paclitaxel and Gemcitabine)
Participants received nab-paclitaxel, 125 mg/m^2, IV infusion and gemcitabine, 1000 mg/m^2, IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle = 28 days).
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m^2 and gemcitabine, 1000 mg/m^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle. Participants also received selicrelumab, 16 mg, SC injection on Day 1 of Cycles 1-4 and every third cycle thereafter (i.e. Cycles 7, 10, 13 etc.) of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants received atezolizumab, 840 mg, and bevacizumab, 10 mg/kg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel 125 mg/m^2, and gemcitabine, 1000 mg/m^2 also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants received AB928, 150 mg, orally, QD on Days 1 to 28 of each cycle; atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle and nab-paclitaxel, 125 mg/m^2, and gemcitabine, 1000 mg/m^2, also administered as IV infusion, on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants received atezolizumab, 840 mg and tiragolumab, 420 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m^2 and gemcitabine, 1000 mg/m^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants received atezolizumab, 1680 mg and tocilizumab, 8 mg/kg, IV infusion on Days 1 of each cycle along with nab-paclitaxel, 125 mg/m^2 and gemcitabine, 1000 mg/m^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants who progressed on a prior gemcitabine-based regimen received mFOLFOX6 which is oxaliplatin, 85 mg/m^2 and leucovorin, 400 mg/m^2 as IV infusion, and 5-fluorouracil, 400 mg/m^2, IV push on Days 1 and 15 of each cycle along with 5-fluorouracil, 2400 mg/m^2, IV continuous infusion on Days 1, 2, 15 and 16 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
BG007
Stage 1 Cohort 2: Control (Nab-Paclitaxel and Gemcitabine)
Participants who progressed on a prior fluoropyrimidine-based regimen received nab-paclitaxel, 125 mg/m^2 and gemcitabine, 1000 mg/m^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
BG008
Stage 1 Cohort 2: Atezolizumab + BL-8040
Participants received BL-8040, 1.25 mg/kg, SC injection on Days 1-5 of the first week, as priming treatment, and thereafter three times a week (Days 1, 3, 5, 8, 10, 12, 15, 17, and 19) along with atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
BG009
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and cobimetinib 60 mg, orally, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
BG010
Stage 1 Cohort 2: Atezolizumab + PEGPH20
Participants received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and PEGPH20, 3 µg/kg, IV infusion on Days 1, 8 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
BG011
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q3W
Participants received atezolizumab, 1200 mg, IV infusion and RO6874281, 10 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
BG012
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q2W
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and RO6874281, 10 mg, IV infusion on Day 1 and 15 mg on Days 8, 15, and 22 of Cycle 1 and thereafter 15 mg on Days 1 and 15 of subsequent cycles until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
BG013
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00035
BG0019
BG00225
BG00316
BG00442
BG00531
BG00625
BG00725
BG00816
BG00915
BG01071
BG01116
BG01215
BG013341
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
18-64 years
Title
Measurements
BG00015
BG0016
BG00213
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00013
BG0014
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
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
Stage 1: Percentage of Participants With Objective Response (OR), as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
OR was defined as a complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart during Stage 1 as determined by the investigator using RECIST v.1.1. Objective response rate (ORR) was defined as the percentage of participants with OR. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD. 95% confidence intervals (CI) for rates were constructed using Clopper-Pearson method. Percentages have been rounded off.
Efficacy population included participants in the safety population who received at least one dose of study drug and who had at least one baseline and one on-study tumor assessment.
Posted
Number
95% Confidence Interval
percentage of participants
Up to 33.3 months
ID
Title
Description
OG000
Stage 1 Cohort 1 : Control (Chemotherapy: Nab-Paclitaxel and Gemcitabine)
Participants received nab-paclitaxel, 125 mg/m^2, IV infusion and gemcitabine, 1000 mg/m^2, IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle = 28 days).
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m^2 and gemcitabine, 1000 mg/m^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle. Participants also received selicrelumab, 16 mg, SC injection on Day 1 of Cycles 1-4 and every third cycle thereafter (i.e. Cycles 7, 10, 13 etc.) of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants received atezolizumab, 840 mg, and bevacizumab, 10 mg/kg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel 125 mg/m^2, and gemcitabine, 1000 mg/m^2 also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants received AB928, 150 mg, orally, QD on Days 1 to 28 of each cycle; atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle and nab-paclitaxel, 125 mg/m^2, and gemcitabine, 1000 mg/m^2, also administered as IV infusion, on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants received atezolizumab, 840 mg and tiragolumab, 420 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m^2 and gemcitabine, 1000 mg/m^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Units
Counts
Participants
OG00032
OG0019
OG00225
OG003
Title
Denominators
Categories
Title
Measurements
OG00037.5(21.10 to 56.31)
OG00155.6(21.20 to 86.30)
OG00248.0(27.80 to 68.69)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Difference in ORR
18.06
2-Sided
95
-25.60
61.71
Superiority
OG000
OG002
Secondary
Number of Participants With Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
Safety population included all participants who received any amount of study treatment.
Posted
Count of Participants
Participants
Up to 33.3 months
ID
Title
Description
OG000
Stage 1 Cohort 1 : Control (Chemotherapy: Nab-Paclitaxel and Gemcitabine)
Participants received nab-paclitaxel, 125 mg/m^2, IV infusion and gemcitabine, 1000 mg/m^2, IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle = 28 days).
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m^2 and gemcitabine, 1000 mg/m^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle. Participants also received selicrelumab, 16 mg, SC injection on Day 1 of Cycles 1-4 and every third cycle thereafter (i.e. Cycles 7, 10, 13 etc.) of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Secondary
Stage 1: Progression-Free Survival (PFS), as Determined by Investigator According to RECIST v1.1
PFS was defined as the time from study treatment initiation to the first occurrence of documented PD, as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Kaplan-Meier (K-M) method was used to estimate PFS.
Efficacy population included participants in the safety population who received at least one dose of study drug and who had at least one baseline and one on-study tumor assessment.
Posted
Median
95% Confidence Interval
months
Up to 33.3 months
ID
Title
Description
OG000
Stage 1 Cohort 1 : Control (Chemotherapy: Nab-Paclitaxel and Gemcitabine)
Participants received nab-paclitaxel, 125 mg/m^2, IV infusion and gemcitabine, 1000 mg/m^2, IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle = 28 days).
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m^2 and gemcitabine, 1000 mg/m^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle. Participants also received selicrelumab, 16 mg, SC injection on Day 1 of Cycles 1-4 and every third cycle thereafter (i.e. Cycles 7, 10, 13 etc.) of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Secondary
Stage 1: Overall Survival (OS), as Determined by Investigator According to RECIST v1.1
OS was defined as the time from randomization to death from any cause. K-M method was used to estimate OS.
Efficacy population included participants in the safety population who received at least one dose of study drug and who had at least one baseline and one on-study tumor assessment.
Posted
Median
95% Confidence Interval
months
Up to 33.3 months
ID
Title
Description
OG000
Stage 1 Cohort 1 : Control (Chemotherapy: Nab-Paclitaxel and Gemcitabine)
Participants received nab-paclitaxel, 125 mg/m^2, IV infusion and gemcitabine, 1000 mg/m^2, IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle = 28 days).
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m^2 and gemcitabine, 1000 mg/m^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle. Participants also received selicrelumab, 16 mg, SC injection on Day 1 of Cycles 1-4 and every third cycle thereafter (i.e. Cycles 7, 10, 13 etc.) of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
OS was defined as the time from randomization to death from any cause. OS rate at 6 months was defined as the percentage of participants who did not experience death from any cause at 6 months from randomization. K-M method was used to estimate OS. Percentages have been rounded off.
Efficacy population included participants in the safety population who received at least one dose of study drug and who had at least one baseline and one on-study tumor assessment.
Posted
Number
95% Confidence Interval
percentage of participants
Month 6
ID
Title
Description
OG000
Stage 1 Cohort 1 : Control (Chemotherapy: Nab-Paclitaxel and Gemcitabine)
Participants received nab-paclitaxel, 125 mg/m^2, IV infusion and gemcitabine, 1000 mg/m^2, IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle = 28 days).
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m^2 and gemcitabine, 1000 mg/m^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle. Participants also received selicrelumab, 16 mg, SC injection on Day 1 of Cycles 1-4 and every third cycle thereafter (i.e. Cycles 7, 10, 13 etc.) of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Secondary
Stage 1: Duration of Response (DOR), as Determined by Investigator According to RECIST v1.1
DOR was defined as time from first occurrence of a documented OR until the time of documented PD or death from any cause, whichever occurs first as determined by investigator assessment using RECIST v1.1. DOR was calculated for participants who had a best confirmed OR of CR/PR. CR=the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR=at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. PD=at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. K-M method was used to estimate DOR.
Efficacy population included participants in the safety population who received at least one dose of study drug and who had at least one baseline and one on-study tumor assessment. Overall number analyzed included participants with OR i.e responders.
Posted
Median
95% Confidence Interval
months
Up to 33.3 months
ID
Title
Description
OG000
Stage 1 Cohort 1 : Control (Chemotherapy: Nab-Paclitaxel and Gemcitabine)
Participants received nab-paclitaxel, 125 mg/m^2, IV infusion and gemcitabine, 1000 mg/m^2, IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle = 28 days).
Stage 1: Percentage of Participants With Disease Control (DC), as Determined by Investigator According to RECIST v1.1
DC was defined as stable disease (SD) for ≥ 12 weeks or a CR or PR, as determined by the investigator according to RECIST v1.1 Disease control rate (DCR) was defined as the percentage of participants with DC. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Percentages have been rounded off.
Efficacy population included participants in the safety population who received at least one dose of study drug and who had at least one baseline and one on-study tumor assessment.
Posted
Number
95% Confidence Interval
percentage of participants
Up to 33.3 months
ID
Title
Description
OG000
Stage 1 Cohort 1 : Control (Chemotherapy: Nab-Paclitaxel and Gemcitabine)
Participants received nab-paclitaxel, 125 mg/m^2, IV infusion and gemcitabine, 1000 mg/m^2, IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle = 28 days).
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m^2 and gemcitabine, 1000 mg/m^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle. Participants also received selicrelumab, 16 mg, SC injection on Day 1 of Cycles 1-4 and every third cycle thereafter (i.e. Cycles 7, 10, 13 etc.) of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Time Frame
Up to 33.3 months
Description
Safety population included all participants who received any amount of study treatment.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Stage 1 Cohort 1 : Control (Chemotherapy: Nab-Paclitaxel and Gemcitabine)
Participants received nab-paclitaxel, 125 mg/m^2, IV infusion and gemcitabine, 1000 mg/m^2, IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle = 28 days).
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m^2 and gemcitabine, 1000 mg/m^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle. Participants also received selicrelumab, 16 mg, SC injection on Day 1 of Cycles 1-4 and every third cycle thereafter (i.e. Cycles 7, 10, 13 etc.) of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants received atezolizumab, 840 mg, and bevacizumab, 10 mg/kg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel 125 mg/m^2, and gemcitabine, 1000 mg/m^2 also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants received AB928, 150 mg, orally, QD on Days 1 to 28 of each cycle; atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle and nab-paclitaxel, 125 mg/m^2, and gemcitabine, 1000 mg/m^2, also administered as IV infusion, on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants received atezolizumab, 840 mg and tiragolumab, 420 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m^2 and gemcitabine, 1000 mg/m^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants received atezolizumab, 1680 mg and tocilizumab, 8 mg/kg, IV infusion on Days 1 of each cycle along with nab-paclitaxel, 125 mg/m^2 and gemcitabine, 1000 mg/m^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants who progressed on a prior gemcitabine-based regimen received mFOLFOX6 which is oxaliplatin, 85 mg/m^2 and leucovorin, 400 mg/m^2 as IV infusion, and 5-fluorouracil, 400 mg/m^2, IV push on Days 1 and 15 of each cycle along with 5-fluorouracil, 2400 mg/m^2, IV continuous infusion on Days 1, 2, 15 and 16 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
19
23
10
23
21
23
EG007
Stage 1 Cohort 2: Control (Nab-Paclitaxel and Gemcitabine)
Participants who progressed on a prior fluoropyrimidine-based regimen received nab-paclitaxel, 125 mg/m^2 and gemcitabine, 1000 mg/m^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
21
23
12
23
23
23
EG008
Stage 1 Cohort 2: Atezolizumab + BL-8040
Participants received BL-8040, 1.25 mg/kg, SC injection on Days 1-5 of the first week, as priming treatment, and thereafter three times a week (Days 1, 3, 5, 8, 10, 12, 15, 17, and 19) along with atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
14
15
4
15
15
15
EG009
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and cobimetinib 60 mg, orally, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
11
14
8
14
13
14
EG010
Stage 1 Cohort 2: Atezolizumab + PEGPH20
Participants received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and PEGPH20, 3 µg/kg, IV infusion on Days 1, 8 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
60
66
30
66
65
66
EG011
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q3W
Participants received atezolizumab, 1200 mg, IV infusion and RO6874281, 10 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
14
15
7
15
15
15
EG012
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q2W
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and RO6874281, 10 mg, IV infusion on Day 1 and 15 mg on Days 8, 15, and 22 of Cycle 1 and thereafter 15 mg on Days 1 and 15 of subsequent cycles until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
14
14
2
14
14
14
EG013
Stage 2 Cohort 2: Atezolizumab + Cobimetinib
Participants in Cohort 2 control and experimental arms (other than atezolizumab + cobimetinib) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and met the eligibility criteria to enroll in Stage 2 received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and cobimetinib, 60 mg, orally, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
14
14
7
14
13
14
EG014
Stage 2 Cohort 2: Atezolizumab + RO6874281 Q3W
Participants in cohort 2 control and experimental arms (other than atezolizumab + RO6874281 Q3W) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 received atezolizumab, 1200 mg, IV infusion and RO6874281, 10 mg, as IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
5
6
2
6
6
6
EG015
Stage 2 Cohort 2: Atezolizumab + RO6874281 Q2W
Participants in cohort 2 control and experimental arms (other than atezolizumab + RO6874281 Q2W) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and RO6874281, 10 mg, IV infusion on Day 1 and 15 mg on Days 8, 15, and 22 of Cycle 1 and thereafter 15 mg on Days 1 and 15 of subsequent cycles until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
1
1
0
1
0
1
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG0030 events0 affected15 at risk
EG0041 events1 affected41 at risk
EG0051 events1 affected30 at risk
EG0061 events1 affected23 at risk
EG0070 events0 affected23 at risk
EG0080 events0 affected15 at risk
EG0090 events0 affected14 at risk
EG0100 events0 affected66 at risk
EG0110 events0 affected15 at risk
EG0120 events0 affected14 at risk
EG0130 events0 affected14 at risk
EG0140 events0 affected6 at risk
EG0150 events0 affected1 at risk
Disseminated intravascular coagulation
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Haemolytic uraemic syndrome
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Splenic infarction
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Thrombotic microangiopathy
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0013 events2 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Atrioventricular block complete
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Inappropriate antidiuretic hormone secretion
Endocrine disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Duodenal obstruction
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Duodenal perforation
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Duodenal stenosis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Ileal perforation
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Intestinal mass
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Mechanical ileus
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Pancreatic duct obstruction
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Retroperitoneal haemorrhage
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Small intestinal perforation
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Asthenia
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Chest pain
General disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Chills
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Death
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Fatigue
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Gait disturbance
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Influenza like illness
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Oedema peripheral
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Pyrexia
General disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0014 events3 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Bile duct stenosis
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Biliary obstruction
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Cholangitis acute
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Drug-induced liver injury
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Jaundice cholestatic
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Arthritis infective
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Biliary tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Device related infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Enterocolitis infectious
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Liver abscess
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Peritonitis bacterial
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected32 at risk
EG0012 events2 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Sepsis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected32 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Septic shock
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Spontaneous bacterial peritonitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Stoma site infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Sweat gland infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Systemic candida
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Toxicity to various agents
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Amylase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Lipase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Liver function test abnormal
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Liver function test increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Platelet count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Embolic cerebellar infarction
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Embolic cerebral infarction
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Guillain-Barre syndrome
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Middle cerebral artery stroke
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Peroneal nerve palsy
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Syncope
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Device dislocation
Product Issues
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected9 at risk
EG0024 events3 affected25 at risk
EG003
Immune-mediated nephritis
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0004 events3 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected32 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Hidradenitis
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Pseudocellulitis
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Aneurysm
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Angiodysplasia
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Embolism
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Hypertension
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Hypotension
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Shock haemorrhagic
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Vena cava thrombosis
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG00015 events14 affected32 at risk
EG0015 events4 affected9 at risk
EG00211 events10 affected25 at risk
EG0039 events9 affected15 at risk
EG00419 events13 affected41 at risk
EG0056 events6 affected30 at risk
EG0064 events4 affected23 at risk
EG0077 events6 affected23 at risk
EG0083 events3 affected15 at risk
EG0092 events2 affected14 at risk
EG0109 events8 affected66 at risk
EG0111 events1 affected15 at risk
EG0121 events1 affected14 at risk
EG0133 events3 affected14 at risk
EG0143 events2 affected6 at risk
EG0150 events0 affected1 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Lymph node pain
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG00013 events10 affected32 at risk
EG0011 events1 affected9 at risk
EG0028 events4 affected25 at risk
EG003
Splenic infarction
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0005 events4 affected32 at risk
EG0010 events0 affected9 at risk
EG0023 events3 affected25 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0013 events2 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0023 events3 affected25 at risk
EG003
Central serous chorioretinopathy
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Diplopia
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Dry eye
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Eye pain
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Eyelid oedema
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Halo vision
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Periorbital oedema
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Photopsia
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Retinal tear
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Vision blurred
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Visual impairment
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0003 events2 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected32 at risk
EG0010 events0 affected9 at risk
EG0022 events2 affected25 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG00010 events7 affected32 at risk
EG0013 events3 affected9 at risk
EG0025 events5 affected25 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected32 at risk
EG0011 events1 affected9 at risk
EG0026 events4 affected25 at risk
EG003
Anal haemorrhage
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 events1 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG00012 events12 affected32 at risk
EG0012 events2 affected9 at risk
EG0025 events5 affected25 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG00016 events13 affected32 at risk
EG0012 events2 affected9 at risk
EG00214 events9 affected25 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected32 at risk
EG0011 events1 affected9 at risk
EG0022 events1 affected25 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected32 at risk
EG0010 events0 affected9 at risk
EG0023 events3 affected25 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected32 at risk
EG0011 events1 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected9 at risk
EG0024 events4 affected25 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0022 events2 affected25 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG00020 events17 affected32 at risk
EG0017 events7 affected9 at risk
EG00212 events9 affected25 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Oral dysaesthesia
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Pancreatic failure
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Paraesthesia oral
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected9 at risk
EG0022 events2 affected25 at risk
EG003
Retching
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0012 events1 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0005 events4 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Tongue ulceration
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0009 events8 affected32 at risk
EG0016 events3 affected9 at risk
EG00215 events10 affected25 at risk
EG003
Adverse drug reaction
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Asthenia
General disorders
MedDRA 27.1
Systematic Assessment
EG0007 events4 affected32 at risk
EG0010 events0 affected9 at risk
EG0024 events3 affected25 at risk
EG003
Chest discomfort
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Chest pain
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0022 events2 affected25 at risk
EG003
Chills
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0013 events3 affected9 at risk
EG0022 events2 affected25 at risk
EG003
Face oedema
General disorders
MedDRA 27.1
Systematic Assessment
EG0002 events1 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Fatigue
General disorders
MedDRA 27.1
Systematic Assessment
EG00022 events18 affected32 at risk
EG0017 events5 affected9 at risk
EG00216 events11 affected25 at risk
EG003
Feeling cold
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Feeling hot
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Gait disturbance
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0022 events2 affected25 at risk
EG003
Generalised oedema
General disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Hernia pain
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Influenza like illness
General disorders
MedDRA 27.1
Systematic Assessment
EG0007 events5 affected32 at risk
EG0012 events2 affected9 at risk
EG0022 events2 affected25 at risk
EG003
Injection site pain
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Injection site reaction
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0014 events4 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Localised oedema
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Malaise
General disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected32 at risk
EG0011 events1 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 27.1
Systematic Assessment
EG0004 events3 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Nodule
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Oedema
General disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Oedema peripheral
General disorders
MedDRA 27.1
Systematic Assessment
EG00017 events11 affected32 at risk
EG0014 events4 affected9 at risk
EG0027 events7 affected25 at risk
EG003
Pain
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Peripheral swelling
General disorders
MedDRA 27.1
Systematic Assessment
EG0003 events1 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Pyrexia
General disorders
MedDRA 27.1
Systematic Assessment
EG00013 events11 affected32 at risk
EG0016 events5 affected9 at risk
EG0024 events3 affected25 at risk
EG003
Temperature intolerance
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Bile duct stenosis
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Biliary obstruction
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Drug-induced liver injury
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Jaundice cholestatic
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Ocular icterus
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected32 at risk
EG0010 events0 affected9 at risk
EG0023 events3 affected25 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected9 at risk
EG0022 events2 affected25 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Influenza
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Klebsiella bacteraemia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Mucosal infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Nail infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Postoperative abscess
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Spontaneous bacterial peritonitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Systemic candida
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0023 events2 affected25 at risk
EG003
Vascular access site infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Injection related reaction
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Stoma site discomfort
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Vascular pseudoaneurysm
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0008 events8 affected32 at risk
EG0014 events3 affected9 at risk
EG0028 events6 affected25 at risk
EG003
Amylase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Aspartate aminotransferase decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0007 events7 affected32 at risk
EG0014 events4 affected9 at risk
EG0026 events5 affected25 at risk
EG003
Blood albumin decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected32 at risk
EG0012 events2 affected9 at risk
EG0022 events2 affected25 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0011 events1 affected9 at risk
EG0022 events2 affected25 at risk
EG003
Blood creatine increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected32 at risk
EG0010 events0 affected9 at risk
EG0022 events2 affected25 at risk
EG003
Blood potassium decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0022 events2 affected25 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0022 events2 affected25 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Lipase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Liver function test abnormal
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Liver function test increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected9 at risk
EG0022 events2 affected25 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected32 at risk
EG0012 events1 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Lymphocyte count increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0009 events6 affected32 at risk
EG0015 events4 affected9 at risk
EG00211 events8 affected25 at risk
EG003
Platelet count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0004 events4 affected32 at risk
EG0014 events3 affected9 at risk
EG0027 events4 affected25 at risk
EG003
Transaminases increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Urine output decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Weight decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0005 events5 affected32 at risk
EG0012 events2 affected9 at risk
EG0026 events6 affected25 at risk
EG003
Weight increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected32 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected25 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0004 events4 affected32 at risk
EG0013 events2 affected9 at risk
EG0023 events3 affected25 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG00014 events13 affected32 at risk
EG0014 events3 affected9 at risk
EG00214 events10 affected25 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0012 events2 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Dyslipidaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Hyperammonaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected32 at risk
EG0011 events1 affected9 at risk
EG0022 events2 affected25 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0004 events4 affected32 at risk
EG0011 events1 affected9 at risk
EG0022 events2 affected25 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected32 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0012 events2 affected9 at risk
EG0022 events2 affected25 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0024 events3 affected25 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected32 at risk
EG0013 events2 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Hypovolaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0005 events5 affected32 at risk
EG0015 events2 affected9 at risk
EG0026 events6 affected25 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected32 at risk
EG0012 events2 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0002 events1 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected32 at risk
EG0013 events3 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0004 events4 affected32 at risk
EG0014 events4 affected9 at risk
EG0023 events3 affected25 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0004 events4 affected32 at risk
EG0011 events1 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected32 at risk
EG0012 events2 affected9 at risk
EG0022 events2 affected25 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected32 at risk
EG0012 events2 affected9 at risk
EG0027 events4 affected25 at risk
EG003
Headache
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0006 events4 affected32 at risk
EG0010 events0 affected9 at risk
EG0027 events5 affected25 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0008 events8 affected32 at risk
EG0010 events0 affected9 at risk
EG00211 events10 affected25 at risk
EG003
Neurotoxicity
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0004 events3 affected32 at risk
EG0010 events0 affected9 at risk
EG0023 events2 affected25 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0009 events8 affected32 at risk
EG0012 events2 affected9 at risk
EG0023 events3 affected25 at risk
EG003
Posterior reversible encephalopathy syndrome
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Tremor
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Affective disorder
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected32 at risk
EG0011 events1 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Depression
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0007 events7 affected32 at risk
EG0013 events2 affected9 at risk
EG0023 events3 affected25 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0022 events2 affected25 at risk
EG003
Chromaturia
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected9 at risk
EG0023 events3 affected25 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Oliguria
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0022 events2 affected25 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0025 events4 affected25 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Ureteric obstruction
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Urinary tract pain
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Testicular disorder
Reproductive system and breast disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Catarrh
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0007 events7 affected32 at risk
EG0013 events3 affected9 at risk
EG0029 events6 affected25 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0006 events6 affected32 at risk
EG0012 events2 affected9 at risk
EG0026 events6 affected25 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected32 at risk
EG0013 events3 affected9 at risk
EG0026 events6 affected25 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Lower respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Nasal septum perforation
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0022 events2 affected25 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0022 events2 affected25 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected9 at risk
EG0022 events2 affected25 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected32 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG00014 events14 affected32 at risk
EG0013 events3 affected9 at risk
EG0024 events4 affected25 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0003 events2 affected32 at risk
EG0010 events0 affected9 at risk
EG0022 events2 affected25 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0022 events2 affected25 at risk
EG003
Nail discolouration
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Nail dystrophy
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Nail toxicity
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0022 events2 affected25 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Onycholysis
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0022 events2 affected25 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Post inflammatory pigmentation change
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Precancerous skin lesion
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0008 events5 affected32 at risk
EG0011 events1 affected9 at risk
EG0028 events5 affected25 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0009 events8 affected32 at risk
EG0011 events1 affected9 at risk
EG0027 events7 affected25 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected32 at risk
EG0012 events2 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected9 at risk
EG0022 events1 affected25 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected32 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0022 events2 affected25 at risk
EG003
Embolism
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Embolism venous
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Flushing
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Haematoma
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Hot flush
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Hypertension
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected32 at risk
EG0011 events1 affected9 at risk
EG00213 events9 affected25 at risk
EG003
Hypotension
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected32 at risk
EG0012 events2 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Superficial vein thrombosis
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected9 at risk
EG0021 events1 affected25 at risk
EG003
Thrombosis
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected25 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Participants received atezolizumab, 1680 mg and tocilizumab, 8 mg/kg, IV infusion on Days 1 of each cycle along with nab-paclitaxel, 125 mg/m^2 and gemcitabine, 1000 mg/m^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants who progressed on a prior gemcitabine-based regimen received mFOLFOX6 which is oxaliplatin, 85 mg/m^2 and leucovorin, 400 mg/m^2 as IV infusion, and 5-fluorouracil, 400 mg/m^2, IV push on Days 1 and 15 of each cycle along with 5-fluorouracil, 2400 mg/m^2, IV continuous infusion on Days 1, 2, 15 and 16 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
OG007
Stage 1 Cohort 2: Control (Nab-Paclitaxel and Gemcitabine)
Participants who progressed on a prior fluoropyrimidine-based regimen received nab-paclitaxel, 125 mg/m^2 and gemcitabine, 1000 mg/m^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
OG008
Stage 1 Cohort 2: Atezolizumab + BL-8040
Participants received BL-8040, 1.25 mg/kg, SC injection on Days 1-5 of the first week, as priming treatment, and thereafter three times a week (Days 1, 3, 5, 8, 10, 12, 15, 17, and 19) along with atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
OG009
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and cobimetinib 60 mg, orally, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
OG010
Stage 1 Cohort 2: Atezolizumab + PEGPH20
Participants received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and PEGPH20, 3 µg/kg, IV infusion on Days 1, 8 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
OG011
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q3W
Participants received atezolizumab, 1200 mg, IV infusion and RO6874281, 10 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
OG012
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q2W
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and RO6874281, 10 mg, IV infusion on Day 1 and 15 mg on Days 8, 15, and 22 of Cycle 1 and thereafter 15 mg on Days 1 and 15 of subsequent cycles until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants received atezolizumab, 840 mg, and bevacizumab, 10 mg/kg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel 125 mg/m^2, and gemcitabine, 1000 mg/m^2 also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants received AB928, 150 mg, orally, QD on Days 1 to 28 of each cycle; atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle and nab-paclitaxel, 125 mg/m^2, and gemcitabine, 1000 mg/m^2, also administered as IV infusion, on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants received atezolizumab, 840 mg and tiragolumab, 420 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m^2 and gemcitabine, 1000 mg/m^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants received atezolizumab, 1680 mg and tocilizumab, 8 mg/kg, IV infusion on Days 1 of each cycle along with nab-paclitaxel, 125 mg/m^2 and gemcitabine, 1000 mg/m^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants who progressed on a prior gemcitabine-based regimen received mFOLFOX6 which is oxaliplatin, 85 mg/m^2 and leucovorin, 400 mg/m^2 as IV infusion, and 5-fluorouracil, 400 mg/m^2, IV push on Days 1 and 15 of each cycle along with 5-fluorouracil, 2400 mg/m^2, IV continuous infusion on Days 1, 2, 15 and 16 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
OG007
Stage 1 Cohort 2: Control (Nab-Paclitaxel and Gemcitabine)
Participants who progressed on a prior fluoropyrimidine-based regimen received nab-paclitaxel, 125 mg/m^2 and gemcitabine, 1000 mg/m^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
OG008
Stage 1 Cohort 2: Atezolizumab + BL-8040
Participants received BL-8040, 1.25 mg/kg, SC injection on Days 1-5 of the first week, as priming treatment, and thereafter three times a week (Days 1, 3, 5, 8, 10, 12, 15, 17, and 19) along with atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
OG009
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and cobimetinib 60 mg, orally, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
OG010
Stage 1 Cohort 2: Atezolizumab + PEGPH20
Participants received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and PEGPH20, 3 µg/kg, IV infusion on Days 1, 8 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
OG011
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q3W
Participants received atezolizumab, 1200 mg, IV infusion and RO6874281, 10 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
OG012
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q2W
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and RO6874281, 10 mg, IV infusion on Day 1 and 15 mg on Days 8, 15, and 22 of Cycle 1 and thereafter 15 mg on Days 1 and 15 of subsequent cycles until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
OG013
Stage 2 Cohort 2: Atezolizumab + Cobimetinib
Participants in Cohort 2 control and experimental arms (other than atezolizumab + cobimetinib) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 and met the eligibility criteria to enroll in Stage 2 received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and cobimetinib, 60 mg, orally, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
OG014
Stage 2 Cohort 2: Atezolizumab + RO6874281 Q3W
Participants in cohort 2 control and experimental arms (other than atezolizumab + RO6874281 Q3W) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 received atezolizumab, 1200 mg, IV infusion and RO6874281, 10 mg, as IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
OG015
Stage 2 Cohort 2: Atezolizumab + RO6874281 Q2W
Participants in cohort 2 control and experimental arms (other than atezolizumab + RO6874281 Q2W) who experienced PD, loss of clinical benefit, or unacceptable toxicity during Stage 1 received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and RO6874281, 10 mg, IV infusion on Day 1 and 15 mg on Days 8, 15, and 22 of Cycle 1 and thereafter 15 mg on Days 1 and 15 of subsequent cycles until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants received atezolizumab, 840 mg, and bevacizumab, 10 mg/kg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel 125 mg/m^2, and gemcitabine, 1000 mg/m^2 also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants received AB928, 150 mg, orally, QD on Days 1 to 28 of each cycle; atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle and nab-paclitaxel, 125 mg/m^2, and gemcitabine, 1000 mg/m^2, also administered as IV infusion, on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants received atezolizumab, 840 mg and tiragolumab, 420 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m^2 and gemcitabine, 1000 mg/m^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants received atezolizumab, 1680 mg and tocilizumab, 8 mg/kg, IV infusion on Days 1 of each cycle along with nab-paclitaxel, 125 mg/m^2 and gemcitabine, 1000 mg/m^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants who progressed on a prior gemcitabine-based regimen received mFOLFOX6 which is oxaliplatin, 85 mg/m^2 and leucovorin, 400 mg/m^2 as IV infusion, and 5-fluorouracil, 400 mg/m^2, IV push on Days 1 and 15 of each cycle along with 5-fluorouracil, 2400 mg/m^2, IV continuous infusion on Days 1, 2, 15 and 16 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
OG007
Stage 1 Cohort 2: Control (Nab-Paclitaxel and Gemcitabine)
Participants who progressed on a prior fluoropyrimidine-based regimen received nab-paclitaxel, 125 mg/m^2 and gemcitabine, 1000 mg/m^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
OG008
Stage 1 Cohort 2: Atezolizumab + BL-8040
Participants received BL-8040, 1.25 mg/kg, SC injection on Days 1-5 of the first week, as priming treatment, and thereafter three times a week (Days 1, 3, 5, 8, 10, 12, 15, 17, and 19) along with atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
OG009
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and cobimetinib 60 mg, orally, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
OG010
Stage 1 Cohort 2: Atezolizumab + PEGPH20
Participants received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and PEGPH20, 3 µg/kg, IV infusion on Days 1, 8 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
OG011
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q3W
Participants received atezolizumab, 1200 mg, IV infusion and RO6874281, 10 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
OG012
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q2W
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and RO6874281, 10 mg, IV infusion on Day 1 and 15 mg on Days 8, 15, and 22 of Cycle 1 and thereafter 15 mg on Days 1 and 15 of subsequent cycles until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Units
Counts
Participants
OG00032
OG0019
OG00225
OG00315
OG00441
OG00530
OG00623
OG00723
OG00814
OG00914
OG01066
OG01115
OG01214
Title
Denominators
Categories
Title
Measurements
OG0006.11(5.13 to 9.92)
OG0014.04(3.02 to 6.97)
OG0027.18(5.03 to 9.82)
OG0038.21(5.91 to 11.10)
OG0045.82(4.40 to 7.52)
OG0055.39(4.17 to 8.21)
OG0062.76(1.45 to 5.52)
OG0072.53(1.77 to 4.04)
OG0081.64(1.41 to 1.87)
OG0091.28(1.15 to 1.84)
OG0101.51(1.38 to 2.56)
OG0111.38(1.38 to 2.66)
OG0121.46(1.31 to 1.58)
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)
1.12
2-Sided
95
0.48
2.64
Superiority
OG000
OG002
Hazard Ratio (HR)
1.17
2-Sided
95
0.66
2.08
Superiority
OG000
OG003
Hazard Ratio (HR)
0.60
2-Sided
95
0.29
1.23
Superiority
OG000
OG004
Hazard Ratio (HR)
1.13
2-Sided
95
0.67
1.89
Superiority
OG000
OG005
Hazard Ratio (HR)
1.07
2-Sided
95
0.61
1.87
Superiority
OG006
OG008
Hazard Ratio (HR)
2.13
2-Sided
95
0.96
4.75
Superiority
OG006
OG009
Hazard Ratio (HR)
3.63
2-Sided
95
1.54
8.57
Superiority
OG006
OG010
Hazard Ratio (HR)
1.15
2-Sided
95
0.68
1.92
Superiority
OG006
OG011
Hazard Ratio (HR)
1.48
2-Sided
95
0.72
3.05
Superiority
OG006
OG012
Hazard Ratio (HR)
1.74
2-Sided
95
0.84
3.06
Superiority
Participants received atezolizumab, 840 mg, and bevacizumab, 10 mg/kg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel 125 mg/m^2, and gemcitabine, 1000 mg/m^2 also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants received AB928, 150 mg, orally, QD on Days 1 to 28 of each cycle; atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle and nab-paclitaxel, 125 mg/m^2, and gemcitabine, 1000 mg/m^2, also administered as IV infusion, on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants received atezolizumab, 840 mg and tiragolumab, 420 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m^2 and gemcitabine, 1000 mg/m^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants received atezolizumab, 1680 mg and tocilizumab, 8 mg/kg, IV infusion on Days 1 of each cycle along with nab-paclitaxel, 125 mg/m^2 and gemcitabine, 1000 mg/m^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants who progressed on a prior gemcitabine-based regimen received mFOLFOX6 which is oxaliplatin, 85 mg/m^2 and leucovorin, 400 mg/m^2 as IV infusion, and 5-fluorouracil, 400 mg/m^2, IV push on Days 1 and 15 of each cycle along with 5-fluorouracil, 2400 mg/m^2, IV continuous infusion on Days 1, 2, 15 and 16 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
OG007
Stage 1 Cohort 2: Control (Nab-Paclitaxel and Gemcitabine)
Participants who progressed on a prior fluoropyrimidine-based regimen received nab-paclitaxel, 125 mg/m^2 and gemcitabine, 1000 mg/m^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
OG008
Stage 1 Cohort 2: Atezolizumab + BL-8040
Participants received BL-8040, 1.25 mg/kg, SC injection on Days 1-5 of the first week, as priming treatment, and thereafter three times a week (Days 1, 3, 5, 8, 10, 12, 15, 17, and 19) along with atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
OG009
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and cobimetinib 60 mg, orally, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
OG010
Stage 1 Cohort 2: Atezolizumab + PEGPH20
Participants received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and PEGPH20, 3 µg/kg, IV infusion on Days 1, 8 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
OG011
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q3W
Participants received atezolizumab, 1200 mg, IV infusion and RO6874281, 10 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
OG012
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q2W
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and RO6874281, 10 mg, IV infusion on Day 1 and 15 mg on Days 8, 15, and 22 of Cycle 1 and thereafter 15 mg on Days 1 and 15 of subsequent cycles until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants received atezolizumab, 840 mg, and bevacizumab, 10 mg/kg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel 125 mg/m^2, and gemcitabine, 1000 mg/m^2 also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants received AB928, 150 mg, orally, QD on Days 1 to 28 of each cycle; atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle and nab-paclitaxel, 125 mg/m^2, and gemcitabine, 1000 mg/m^2, also administered as IV infusion, on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants received atezolizumab, 840 mg and tiragolumab, 420 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m^2 and gemcitabine, 1000 mg/m^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants received atezolizumab, 1680 mg and tocilizumab, 8 mg/kg, IV infusion on Days 1 of each cycle along with nab-paclitaxel, 125 mg/m^2 and gemcitabine, 1000 mg/m^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants who progressed on a prior gemcitabine-based regimen received mFOLFOX6 which is oxaliplatin, 85 mg/m^2 and leucovorin, 400 mg/m^2 as IV infusion, and 5-fluorouracil, 400 mg/m^2, IV push on Days 1 and 15 of each cycle along with 5-fluorouracil, 2400 mg/m^2, IV continuous infusion on Days 1, 2, 15 and 16 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
OG007
Stage 1 Cohort 2: Control (Nab-Paclitaxel and Gemcitabine)
Participants who progressed on a prior fluoropyrimidine-based regimen received nab-paclitaxel, 125 mg/m^2 and gemcitabine, 1000 mg/m^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
OG008
Stage 1 Cohort 2: Atezolizumab + BL-8040
Participants received BL-8040, 1.25 mg/kg, SC injection on Days 1-5 of the first week, as priming treatment, and thereafter three times a week (Days 1, 3, 5, 8, 10, 12, 15, 17, and 19) along with atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
OG009
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and cobimetinib 60 mg, orally, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
OG010
Stage 1 Cohort 2: Atezolizumab + PEGPH20
Participants received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and PEGPH20, 3 µg/kg, IV infusion on Days 1, 8 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
OG011
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q3W
Participants received atezolizumab, 1200 mg, IV infusion and RO6874281, 10 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
OG012
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q2W
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and RO6874281, 10 mg, IV infusion on Day 1 and 15 mg on Days 8, 15, and 22 of Cycle 1 and thereafter 15 mg on Days 1 and 15 of subsequent cycles until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Units
Counts
Participants
OG00032
OG0019
OG00225
OG00315
OG00441
OG00530
OG00623
OG00723
OG00814
OG00914
OG01066
OG01115
OG01214
Title
Denominators
Categories
Title
Measurements
OG00087.07(75.23 to 98.91)
OG00155.56(23.09 to 88.02)
OG00283.48(68.67 to 98.28)
OG00380.00(59.76 to 100.00)
OG00472.55(58.72 to 86.37)
OG00586.67(74.50 to 98.83)
OG00678.76(60.06 to 97.46)
OG00753.45(30.72 to 76.19)
OG00827.78(1.17 to 54.39)
OG00941.96(14.01 to 69.91)
OG01051.97(39.29 to 64.65)
OG01143.33(17.35 to 69.32)
OG01250.00(23.81 to 76.19)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Difference in Event Free Rate
-31.51
2-Sided
95
-66.07
3.04
Superiority
OG000
OG002
Difference in Event Free Rate
-3.59
2-Sided
95
-22.55
15.37
Superiority
OG000
OG003
Difference in Event Free Rate
-7.07
2-Sided
95
-30.52
16.38
Superiority
OG000
OG004
Difference in Event Free Rate
-14.52
2-Sided
95
-32.72
3.68
Superiority
OG000
OG005
Difference in Event Free Rate
-0.40
2-Sided
95
-17.38
16.57
Superiority
OG006
OG008
Difference in Event Free Rate
-50.98
2-Sided
95
-83.51
-18.46
Superiority
OG006
OG009
Difference in Event Free Rate
-36.80
2-Sided
95
-70.43
-3.18
Superiority
OG006
OG010
Difference in Event Free Rate
-26.79
2-Sided
95
-49.39
-4.20
Superiority
OG006
OG011
Difference in Event Free Rate
-35.43
2-Sided
95
-67.44
-3.42
Superiority
OG006
OG012
Difference in Event Free Rate
-28.76
2-Sided
95
-60.94
3.42
Superiority
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m^2 and gemcitabine, 1000 mg/m^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle. Participants also received selicrelumab, 16 mg, SC injection on Day 1 of Cycles 1-4 and every third cycle thereafter (i.e. Cycles 7, 10, 13 etc.) of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants received atezolizumab, 840 mg, and bevacizumab, 10 mg/kg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel 125 mg/m^2, and gemcitabine, 1000 mg/m^2 also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants received AB928, 150 mg, orally, QD on Days 1 to 28 of each cycle; atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle and nab-paclitaxel, 125 mg/m^2, and gemcitabine, 1000 mg/m^2, also administered as IV infusion, on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants received atezolizumab, 840 mg and tiragolumab, 420 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m^2 and gemcitabine, 1000 mg/m^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants received atezolizumab, 1680 mg and tocilizumab, 8 mg/kg, IV infusion on Days 1 of each cycle along with nab-paclitaxel, 125 mg/m^2 and gemcitabine, 1000 mg/m^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants who progressed on a prior gemcitabine-based regimen received mFOLFOX6 which is oxaliplatin, 85 mg/m^2 and leucovorin, 400 mg/m^2 as IV infusion, and 5-fluorouracil, 400 mg/m^2, IV push on Days 1 and 15 of each cycle along with 5-fluorouracil, 2400 mg/m^2, IV continuous infusion on Days 1, 2, 15 and 16 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
OG007
Stage 1 Cohort 2: Control (Nab-Paclitaxel and Gemcitabine)
Participants who progressed on a prior fluoropyrimidine-based regimen received nab-paclitaxel, 125 mg/m^2 and gemcitabine, 1000 mg/m^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
OG008
Stage 1 Cohort 2: Atezolizumab + BL-8040
Participants received BL-8040, 1.25 mg/kg, SC injection on Days 1-5 of the first week, as priming treatment, and thereafter three times a week (Days 1, 3, 5, 8, 10, 12, 15, 17, and 19) along with atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
OG009
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and cobimetinib 60 mg, orally, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
OG010
Stage 1 Cohort 2: Atezolizumab + PEGPH20
Participants received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and PEGPH20, 3 µg/kg, IV infusion on Days 1, 8 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
OG011
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q3W
Participants received atezolizumab, 1200 mg, IV infusion and RO6874281, 10 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
OG012
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q2W
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and RO6874281, 10 mg, IV infusion on Day 1 and 15 mg on Days 8, 15, and 22 of Cycle 1 and thereafter 15 mg on Days 1 and 15 of subsequent cycles until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Units
Counts
Participants
OG00012
OG0015
OG00212
OG0034
OG00413
OG0059
OG0062
OG0070
OG0080
OG0090
OG0104
OG0110
OG0121
Title
Denominators
Categories
Title
Measurements
OG0005.40(3.94 to 8.21)
OG0013.35(2.56 to NA)The upper limit of the 95% CI was not estimable due to an insufficient number of participants with events.
OG0028.18(6.34 to 8.74)
OG0034.85(2.86 to NA)The upper limit of the 95% CI was not estimable due to an insufficient number of participants with events.
OG0044.47(3.58 to 10.12)
OG0055.65(4.53 to 10.84)
OG0063.37(2.83 to NA)The upper limit of the 95% CI was not estimable due to an insufficient number of participants with events.
OG0108.15(5.32 to NA)The upper limit of the 95% CI was not estimable due to an insufficient number of participants with events.
OG0126.14(NA to NA)The 95% CI was not estimable due to an insufficient number of participants with events.
Participants received atezolizumab, 840 mg, and bevacizumab, 10 mg/kg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel 125 mg/m^2, and gemcitabine, 1000 mg/m^2 also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants received AB928, 150 mg, orally, QD on Days 1 to 28 of each cycle; atezolizumab 840 mg, IV infusion on Days 1 and 15 of each cycle and nab-paclitaxel, 125 mg/m^2, and gemcitabine, 1000 mg/m^2, also administered as IV infusion, on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants received atezolizumab, 840 mg and tiragolumab, 420 mg, IV infusion on Days 1 and 15 of each cycle along with nab-paclitaxel, 125 mg/m^2 and gemcitabine, 1000 mg/m^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants received atezolizumab, 1680 mg and tocilizumab, 8 mg/kg, IV infusion on Days 1 of each cycle along with nab-paclitaxel, 125 mg/m^2 and gemcitabine, 1000 mg/m^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
Participants who progressed on a prior gemcitabine-based regimen received mFOLFOX6 which is oxaliplatin, 85 mg/m^2 and leucovorin, 400 mg/m^2 as IV infusion, and 5-fluorouracil, 400 mg/m^2, IV push on Days 1 and 15 of each cycle along with 5-fluorouracil, 2400 mg/m^2, IV continuous infusion on Days 1, 2, 15 and 16 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
OG007
Stage 1 Cohort 2: Control (Nab-Paclitaxel and Gemcitabine)
Participants who progressed on a prior fluoropyrimidine-based regimen received nab-paclitaxel, 125 mg/m^2 and gemcitabine, 1000 mg/m^2, also administered as IV infusion on Days 1, 8, and 15 of each cycle until unacceptable toxicity or PD (1 cycle=28 days).
OG008
Stage 1 Cohort 2: Atezolizumab + BL-8040
Participants received BL-8040, 1.25 mg/kg, SC injection on Days 1-5 of the first week, as priming treatment, and thereafter three times a week (Days 1, 3, 5, 8, 10, 12, 15, 17, and 19) along with atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
OG009
Stage 1 Cohort 2: Atezolizumab + Cobimetinib
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and cobimetinib 60 mg, orally, QD on Days 1-21 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).
OG010
Stage 1 Cohort 2: Atezolizumab + PEGPH20
Participants received atezolizumab, 1200 mg, IV infusion on Day 1 of each cycle and PEGPH20, 3 µg/kg, IV infusion on Days 1, 8 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
OG011
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q3W
Participants received atezolizumab, 1200 mg, IV infusion and RO6874281, 10 mg, IV infusion on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days).
OG012
Stage 1 Cohort 2: Atezolizumab + RO6874281 Q2W
Participants received atezolizumab, 840 mg, IV infusion on Days 1 and 15 of each cycle and RO6874281, 10 mg, IV infusion on Day 1 and 15 mg on Days 8, 15, and 22 of Cycle 1 and thereafter 15 mg on Days 1 and 15 of subsequent cycles until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days).