Trial Outcomes & Findings for A Study of Atezolizumab (Tecentriq) in Combination With Bevacizumab to Investigate Safety and Efficacy in Patients With Unresectable Hepatocellular Carcinoma Not Previously Treated With Systemic Therapy-Amethista (NCT NCT04487067)

Last Updated: 2025-09-22

Results Overview

An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Severity of AEs was graded using NCI CTCAE v5.0. Grade 3=Severe/medically significant but not immediately life-threatening, hospitalization/prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; Grade 4=Life-threatening consequences, urgent intervention indicated; Grade 5=Death related to AE.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

152 participants

Primary outcome timeframe

Up to approximately 47.6 months

Results posted on

2025-09-22

Participant Flow

A total of 152 participants with unresectable hepatocellular carcinoma (HCC) and no prior systemic treatment took part in the study at 21 investigative sites in Italy from 25 August 2020 to 13 August 2024.

Participants received atezolizumab in combination with bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Of the 152 participants enrolled, three participants did not receive any treatment.

Participant milestones

Participant milestones
Measure	Atezolizumab + Bevacizumab Participants received atezolizumab, 1200 milligrams (mg) as intravenous (IV) infusion, along with bevacizumab, 15 milligrams/kilogram (mg/kg), also as IV infusion, every 3 weeks (Q3W) on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Overall Study STARTED	152
Overall Study Safety Analysis Population	149
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	131

Reasons for withdrawal

Reasons for withdrawal
Measure	Atezolizumab + Bevacizumab Participants received atezolizumab, 1200 milligrams (mg) as intravenous (IV) infusion, along with bevacizumab, 15 milligrams/kilogram (mg/kg), also as IV infusion, every 3 weeks (Q3W) on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Overall Study Adverse Event	3
Overall Study Death Other Than Progressive Disease	60
Overall Study Death Due To Progressive Disease	40
Overall Study Lost to Follow-up	3
Overall Study Progressive Disease	1
Overall Study Protocol Violation	3
Overall Study Participant Discontinued From Study as per Protocol	6
Overall Study Withdrawal by Subject	15

Baseline Characteristics

A Study of Atezolizumab (Tecentriq) in Combination With Bevacizumab to Investigate Safety and Efficacy in Patients With Unresectable Hepatocellular Carcinoma Not Previously Treated With Systemic Therapy-Amethista

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Atezolizumab + Bevacizumab n=152 Participants Participants received atezolizumab, 1200 mg as IV infusion, along with bevacizumab, 15 mg/kg, also as IV infusion, Q3W on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Age, Continuous	67.1 years STANDARD_DEVIATION 10.52 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants
Sex: Female, Male Male	121 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	141 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	145 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 47.6 months

Population: Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.

Outcome measures

Outcome measures
Measure	Atezolizumab + Bevacizumab n=149 Participants Participants received atezolizumab, 1200 mg as IV infusion, along with bevacizumab, 15 mg/kg, also as IV infusion, Q3W on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Number of Participants With Grade 3-5 National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE V5) Bleeding/Haemorrhage Grade 3	17 Participants
Number of Participants With Grade 3-5 National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE V5) Bleeding/Haemorrhage Grade 4	3 Participants
Number of Participants With Grade 3-5 National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE V5) Bleeding/Haemorrhage Grade 5	2 Participants

SECONDARY outcome

Timeframe: Up to approximately 47.6 months

Population: ITT population included all participants who signed the ICF and were enrolled in the study. Overall number analyzed is the number of participants with data available for analysis.

OS was defined as the time from initiation of study treatment to death from any cause. Kaplan-Meier (K-M) method was used to estimate the OS.

Outcome measures

Outcome measures
Measure	Atezolizumab + Bevacizumab n=149 Participants Participants received atezolizumab, 1200 mg as IV infusion, along with bevacizumab, 15 mg/kg, also as IV infusion, Q3W on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Overall Survival (OS)	20.76 months Interval 16.85 to 26.35

SECONDARY outcome

Timeframe: Up to approximately 47.6 months

Population: Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.

An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs are defined as AEs with onset date on or after the start of the first study treatment component. Number of participants with any TEAEs are reported here.

Outcome measures

Outcome measures
Measure	Atezolizumab + Bevacizumab n=149 Participants Participants received atezolizumab, 1200 mg as IV infusion, along with bevacizumab, 15 mg/kg, also as IV infusion, Q3W on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	144 Participants

SECONDARY outcome

Timeframe: Up to approximately 47.6 months

Population: ITT population included all participants who signed the ICF and were enrolled in the study. Overall number analyzed is the number of participants with data available for analysis.

PFS was defined as the time from initiation of study treatment to the first occurrence of disease progression (PD) or death from any cause (whichever occurs first), as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 millimeters (mm). Participants alive and without any PD were censored at the last assessment date. K-M method was used to estimate the PFS.

Outcome measures

Outcome measures
Measure	Atezolizumab + Bevacizumab n=149 Participants Participants received atezolizumab, 1200 mg as IV infusion, along with bevacizumab, 15 mg/kg, also as IV infusion, Q3W on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Progression-free Survival (PFS)	8.80 months Interval 7.89 to 11.24

SECONDARY outcome

Timeframe: Up to approximately 47.6 months

Population: ITT population included all participants who signed the ICF and were enrolled in the study.

ORR was defined as the percentage of participants with complete or partial response (CR or PR), as determined by the investigator according to RECIST v1.1. CR was defined as disappearance of all target lesions or any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.

Outcome measures

Outcome measures
Measure	Atezolizumab + Bevacizumab n=152 Participants Participants received atezolizumab, 1200 mg as IV infusion, along with bevacizumab, 15 mg/kg, also as IV infusion, Q3W on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Objective Response Rate (ORR)	28.29 percentage of participants Interval 0.2173 to 0.3592

SECONDARY outcome

Timeframe: Up to approximately 47.6 months

Population: ITT population included all participants who signed the ICF and were enrolled in the study. Overall number analyzed is the number of participants with data available for analysis.

TTP was defined as the time from initiation of study treatment to the first occurrence of PD, as determined by the investigator according to RECIST v1.1. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 mm. Participants without any PD were censored at the last assessment date. K-M method was used to estimate the TTP.

Outcome measures

Outcome measures
Measure	Atezolizumab + Bevacizumab n=149 Participants Participants received atezolizumab, 1200 mg as IV infusion, along with bevacizumab, 15 mg/kg, also as IV infusion, Q3W on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Time to Progression (TTP)	11.24 months Interval 8.48 to 15.77

SECONDARY outcome

Timeframe: Up to approximately 47.6 months

Population: ITT population included all participants who signed the ICF and were enrolled in the study. Overall number analyzed is the number of participants with an objective response (CR or PR).

DOR was defined as the time from the first occurrence of a documented objective response (CR or PR) to PD or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1. CR was defined as disappearance of all target lesions or any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 mm. Participants who were alive and without any PD were censored at the last assessment date. K-M method was used to estimate the DOR.

Outcome measures

Outcome measures
Measure	Atezolizumab + Bevacizumab n=43 Participants Participants received atezolizumab, 1200 mg as IV infusion, along with bevacizumab, 15 mg/kg, also as IV infusion, Q3W on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Duration of Response (DOR)	17.35 months Interval 13.54 to 27.24

SECONDARY outcome

Timeframe: Up to approximately 47.6 months

Population: ITT population included all participants who signed the ICF and were enrolled in the study. Overall number analyzed is the number of participants with a progressive disease.

PPS was defined as the time from the first occurrence of PD as determined by the investigator according to RECIST v1.1 to death from any cause. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 mm. Participants who were alive were censored at the last assessment date. K-M method was used to estimate the PPS.

Outcome measures

Outcome measures
Measure	Atezolizumab + Bevacizumab n=97 Participants Participants received atezolizumab, 1200 mg as IV infusion, along with bevacizumab, 15 mg/kg, also as IV infusion, Q3W on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Post-progression Survival (PPS)	11.27 months Interval 8.41 to 13.8

SECONDARY outcome

Timeframe: From Cycle 1 Day 1 to Cycle 63 Day 1 (1 Cycle = 21 days)

Population: Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.

Participants self-reported symptomatic AEs using PRO-CTCAE, a validated item bank used to characterize presence, frequency of occurrence, severity, \&/or degree of interference with daily function of 78 patient-reportable symptomatic treatment toxicities. PRO-CTCAE contains questions that are rated either dichotomously (for determination of presence vs. absence) or on a 5-point Likert scale (for determination of frequency of occurrence,severity,\& interference with daily function). Treatment toxicities can occur with observable signs (e.g.,vomiting)/ non-observable symptoms (e.g.,nausea). A subset of 14 symptoms most applicable to current treatments were selected for this study. Symptoms were selected based on toxicities associated with the drug's class, mechanism of action, or mode of administration, and toxicities reported with the drug in another indication. Number of participants who reported severe symptoms per the PRO-CTCAE questionnaire on Day 1 of each cycle is reported here.

Outcome measures

Outcome measures
Measure	Atezolizumab + Bevacizumab n=149 Participants Participants received atezolizumab, 1200 mg as IV infusion, along with bevacizumab, 15 mg/kg, also as IV infusion, Q3W on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 1 Day 1	39 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 2 Day 1	33 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 3 Day 1	23 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 4 Day 1	30 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 5 Day 1	23 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 6 Day 1	22 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 7 Day 1	17 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 8 Day 1	14 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 9 Day 1	19 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 10 Day 1	16 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 11 Day 1	17 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 12 Day 1	16 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 13 Day 1	13 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 14 Day 1	13 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 15 Day 1	9 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 16 Day 1	8 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 17 Day 1	10 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 18 Day 1	10 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 19 Day 1	8 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 20 Day 1	11 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 21 Day 1	5 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 22 Day 1	6 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 23 Day 1	8 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 24 Day 1	10 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 25 Day 1	8 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 26 Day 1	7 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 27 Day 1	8 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 28 Day 1	10 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 29 Day 1	6 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 30 Day 1	7 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 31 Day 1	7 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 32 Day 1	6 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 33 Day 1	6 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 34 Day 1	7 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 35 Day 1	9 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 36 Day 1	8 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 37 Day 1	7 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 38 Day 1	9 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 39 Day 1	8 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 40 Day 1	8 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 41 Day 1	5 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 42 Day 1	6 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 43 Day 1	3 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 44 Day 1	3 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 45 Day 1	3 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 46 Day 1	2 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 47 Day 1	2 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 48 Day 1	3 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 49 Day 1	3 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 50 Day 1	2 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 51 Day 1	3 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 52 Day 1	2 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 53 Day 1	2 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 54 Day 1	1 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 55 Day 1	1 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 56 Day 1	1 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 57 Day 1	0 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 58 Day 1	0 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 59 Day 1	0 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 60 Day 1	0 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 61 Day 1	0 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 62 Day 1	0 Participants
Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire Cycle 63 Day 1	0 Participants

SECONDARY outcome

Timeframe: From Cycle 1 Day 1 to Cycle 63 Day 1 (1 Cycle = 21 days)

Population: Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.

Participants self-reported symptomatic AEs using PRO-CTCAE, a validated item bank used to characterize presence, frequency of occurrence, severity, \&/or degree of interference with daily function of 78 patient-reportable symptomatic treatment toxicities. PRO-CTCAE contains questions that are rated either dichotomously (for determination of presence vs. absence) or on a 5-point Likert scale (for determination of frequency of occurrence,severity,\& interference with daily function). Treatment toxicities can occur with observable signs (e.g.,vomiting)/ non-observable symptoms (e.g.,nausea). A subset of 14 symptoms most applicable to current treatments were selected for this study. Symptoms were selected based on toxicities associated with the drug's class, mechanism of action, or mode of administration, \&toxicities reported with the drug in another indication. Number of participants who reported very severe symptoms per the PRO-CTCAE questionnaire on Day 1 of each cycle is reported here.

Outcome measures

Outcome measures
Measure	Atezolizumab + Bevacizumab n=149 Participants Participants received atezolizumab, 1200 mg as IV infusion, along with bevacizumab, 15 mg/kg, also as IV infusion, Q3W on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 52 Day 1	1 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 1 Day 1	15 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 2 Day 1	18 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 3 Day 1	12 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 4 Day 1	12 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 5 Day 1	10 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 6 Day 1	11 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 7 Day 1	7 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 8 Day 1	11 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 9 Day 1	7 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 10 Day 1	7 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 11 Day 1	6 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 12 Day 1	5 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 13 Day 1	7 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 14 Day 1	7 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 15 Day 1	7 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 16 Day 1	8 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 17 Day 1	4 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 18 Day 1	5 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 19 Day 1	4 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 20 Day 1	4 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 21 Day 1	1 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 22 Day 1	4 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 23 Day 1	2 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 24 Day 1	3 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 25 Day 1	4 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 26 Day 1	4 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 27 Day 1	3 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 28 Day 1	3 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 29 Day 1	3 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 30 Day 1	2 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 31 Day 1	4 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 32 Day 1	3 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 33 Day 1	3 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 34 Day 1	5 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 35 Day 1	5 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 53 Day 1	1 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 36 Day 1	3 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 37 Day 1	6 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 38 Day 1	4 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 39 Day 1	4 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 40 Day 1	4 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 41 Day 1	4 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 42 Day 1	5 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 43 Day 1	4 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 44 Day 1	4 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 45 Day 1	2 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 46 Day 1	2 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 47 Day 1	1 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 48 Day 1	1 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 49 Day 1	0 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 50 Day 1	1 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 51 Day 1	0 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 54 Day 1	0 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 55 Day 1	1 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 56 Day 1	0 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 57 Day 1	1 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 58 Day 1	0 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 59 Day 1	0 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 60 Day 1	0 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 61 Day 1	0 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 62 Day 1	0 Participants
Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire Cycle 63 Day 1	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to approximately 47.6 months

Population: Per protocol, this is an exploratory outcome measure; therefore, the results have not been reported.

Outcome measures

Outcome data not reported

Adverse Events

Atezolizumab + Bevacizumab

Serious events: 62 serious events

Other events: 142 other events

Deaths: 102 deaths

Serious adverse events

Serious adverse events
Measure	Atezolizumab + Bevacizumab n=149 participants at risk Participants received atezolizumab, 1200 mg as IV infusion, along with bevacizumab, 15 mg/kg, also as IV infusion, Q3W on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Blood and lymphatic system disorders Anaemia	2.0% 3/149 • Number of events 4 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Blood and lymphatic system disorders Iron deficiency anaemia	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Cardiac disorders Angina unstable	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Cardiac disorders Bradycardia	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Cardiac disorders Cardiac arrest	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Cardiac disorders Cardiac failure	0.67% 1/149 • Number of events 5 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Cardiac disorders Myocardial infarction	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Eye disorders Diplopia	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Gastrointestinal disorders Ascites	2.0% 3/149 • Number of events 3 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Gastrointestinal disorders Enterovesical fistula	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Gastrointestinal disorders Gastric haemorrhage	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Gastrointestinal disorders Gastrointestinal haemorrhage	2.0% 3/149 • Number of events 3 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Gastrointestinal disorders Haematemesis	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Gastrointestinal disorders Haemoperitoneum	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Gastrointestinal disorders Large intestinal haemorrhage	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Gastrointestinal disorders Melaena	1.3% 2/149 • Number of events 2 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Gastrointestinal disorders Nausea	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Gastrointestinal disorders Oesophageal varices haemorrhage	2.7% 4/149 • Number of events 4 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Gastrointestinal disorders Pancreatic haemorrhage	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Gastrointestinal disorders Rectal haemorrhage	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Gastrointestinal disorders Small intestinal haemorrhage	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	1.3% 2/149 • Number of events 3 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
General disorders Chest pain	0.67% 1/149 • Number of events 2 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
General disorders Oedema	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
General disorders Oedema peripheral	1.3% 2/149 • Number of events 2 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
General disorders Pyrexia	1.3% 2/149 • Number of events 2 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Hepatobiliary disorders Bile duct stone	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Hepatobiliary disorders Cholangitis	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Hepatobiliary disorders Cholecystitis	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Hepatobiliary disorders Hepatic failure	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Infections and infestations Biliary tract infection	1.3% 2/149 • Number of events 2 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Infections and infestations Brain abscess	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Infections and infestations COVID-19	2.7% 4/149 • Number of events 4 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Infections and infestations COVID-19 pneumonia	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Infections and infestations Gangrene	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Infections and infestations Infection	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Infections and infestations Peri-implantitis	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Infections and infestations Pneumonia	1.3% 2/149 • Number of events 2 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Infections and infestations Sepsis	3.4% 5/149 • Number of events 5 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Injury, poisoning and procedural complications Accidental exposure to product	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Injury, poisoning and procedural complications Femur fracture	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Injury, poisoning and procedural complications Humerus fracture	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Injury, poisoning and procedural complications Infusion related reaction	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Injury, poisoning and procedural complications Thermal burn	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Injury, poisoning and procedural complications Ulna fracture	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Injury, poisoning and procedural complications Wound dehiscence	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Investigations Blood bilirubin increased	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Investigations Electrocardiogram abnormal	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Metabolism and nutrition disorders Hyponatraemia	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Nervous system disorders Ataxia	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Nervous system disorders Encephalopathy	1.3% 2/149 • Number of events 2 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Nervous system disorders Headache	1.3% 2/149 • Number of events 2 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Nervous system disorders Hepatic encephalopathy	1.3% 2/149 • Number of events 2 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Nervous system disorders Hypoglycaemic coma	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Nervous system disorders Syncope	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Nervous system disorders Transient ischaemic attack	1.3% 2/149 • Number of events 3 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Psychiatric disorders Confusional state	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Renal and urinary disorders Acute kidney injury	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Renal and urinary disorders Proteinuria	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Renal and urinary disorders Renal failure	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.4% 5/149 • Number of events 5 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Skin and subcutaneous tissue disorders Dermatitis bullous	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Skin and subcutaneous tissue disorders Purpura	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Surgical and medical procedures Leg amputation	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Vascular disorders Deep vein thrombosis	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Vascular disorders Haemorrhage	1.3% 2/149 • Number of events 2 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Vascular disorders Pelvic venous thrombosis	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Vascular disorders Shock haemorrhagic	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Vascular disorders Thrombophlebitis	0.67% 1/149 • Number of events 1 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.

Other adverse events

Other adverse events
Measure	Atezolizumab + Bevacizumab n=149 participants at risk Participants received atezolizumab, 1200 mg as IV infusion, along with bevacizumab, 15 mg/kg, also as IV infusion, Q3W on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
General disorders Asthenia	43.0% 64/149 • Number of events 97 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
General disorders Pyrexia	21.5% 32/149 • Number of events 38 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
General disorders Fatigue	17.4% 26/149 • Number of events 30 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
General disorders Oedema peripheral	8.1% 12/149 • Number of events 14 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
General disorders Mucosal inflammation	6.7% 10/149 • Number of events 12 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Vascular disorders Hypertension	34.2% 51/149 • Number of events 99 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Gastrointestinal disorders Diarrhoea	28.2% 42/149 • Number of events 64 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Gastrointestinal disorders Abdominal pain	16.8% 25/149 • Number of events 32 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Gastrointestinal disorders Nausea	14.8% 22/149 • Number of events 28 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Gastrointestinal disorders Ascites	10.7% 16/149 • Number of events 18 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Gastrointestinal disorders Abdominal pain upper	9.4% 14/149 • Number of events 16 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Gastrointestinal disorders Constipation	9.4% 14/149 • Number of events 16 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Gastrointestinal disorders Vomiting	9.4% 14/149 • Number of events 15 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Gastrointestinal disorders Stomatitis	6.7% 10/149 • Number of events 10 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Skin and subcutaneous tissue disorders Pruritus	24.2% 36/149 • Number of events 46 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Metabolism and nutrition disorders Decreased Appetite	22.1% 33/149 • Number of events 42 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Renal and urinary disorders Proteinuria	18.8% 28/149 • Number of events 48 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Musculoskeletal and connective tissue disorders Arthralgia	16.1% 24/149 • Number of events 43 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Musculoskeletal and connective tissue disorders Back pain	10.1% 15/149 • Number of events 16 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Respiratory, thoracic and mediastinal disorders Cough	14.1% 21/149 • Number of events 29 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Respiratory, thoracic and mediastinal disorders Epistaxis	12.1% 18/149 • Number of events 23 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Respiratory, thoracic and mediastinal disorders Dysphonia	6.0% 9/149 • Number of events 9 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.4% 8/149 • Number of events 8 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Nervous system disorders Headache	12.1% 18/149 • Number of events 21 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Endocrine disorders Hypothyroidism	11.4% 17/149 • Number of events 20 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Blood and lymphatic system disorders Thrombocytopenia	10.7% 16/149 • Number of events 35 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Blood and lymphatic system disorders Anaemia	10.1% 15/149 • Number of events 17 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Investigations Blood bilirubin increased	8.7% 13/149 • Number of events 21 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Investigations Platelet count decreased	7.4% 11/149 • Number of events 19 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Investigations Aspartate aminotransferase increased	7.4% 11/149 • Number of events 14 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Investigations Alanine aminotransferase increased	5.4% 8/149 • Number of events 10 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Infections and infestations COVID-19	8.7% 13/149 • Number of events 14 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Hepatobiliary disorders Hypertransaminasaemia	6.0% 9/149 • Number of events 13 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.
Hepatobiliary disorders Hyperbilirubinaemia	5.4% 8/149 • Number of events 11 • Other AEs: From initiation of study drug until 30 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) SAEs, and All-cause mortality: From initiation of study drug until 90 days after the final dose or initiation of new systemic anti-cancer therapy, whichever occurs first (up to approximately 47.6 months) Safety analysis population included all enrolled participants who had at least one full or partial administration of atezolizumab plus bevacizumab.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER