Trial Outcomes & Findings for A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection (NCT NCT02450331)

NCT ID: NCT02450331

Last Updated: 2023-06-18

Results Overview

DFS is defined as the time from randomization to the time of first occurrence of a DFS event. DFS events include: local (pelvic) recurrence of UC (including soft tissue and regional lymph nodes); urinary tract recurrence of UC (including all pathological stages and grades); distant metastasis of UC; or death from any cause. Tumor assessment will be performed using radiographic evaluations.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 809 participants
• Primary outcome timeframe: Randomization up to first occurrence of DFS event (up to approximately 50 months)
• Results posted on: 2023-06-18

Participant Flow

Participant milestones

Measure	Observation Participants underwent observation starting on Day 1 for 16 cycles (up to 1 year).	Atezolizumab Participants received intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).
Overall Study STARTED	403	406
Overall Study COMPLETED	171	178
Overall Study NOT COMPLETED	232	228

Reasons for withdrawal

Measure	Observation Participants underwent observation starting on Day 1 for 16 cycles (up to 1 year).	Atezolizumab Participants received intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).
Overall Study Death	162	171
Overall Study Lost to Follow-up	14	12
Overall Study Withdrawal by Subject	55	44
Overall Study Non-specified other	1	1

Baseline Characteristics

A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection

Baseline characteristics by cohort

Measure	Observation n=403 Participants Participants underwent observation starting on Day 1 for 16 cycles (up to 1 year).	Atezolizumab n=406 Participants Participants received intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).	Total n=809 Participants Total of all reporting groups
Age, Continuous	65.9 Years STANDARD_DEVIATION 9.3 • n=5 Participants	66.0 Years STANDARD_DEVIATION 9.0 • n=7 Participants	65.9 Years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male Female	87 Participants n=5 Participants	84 Participants n=7 Participants	171 Participants n=5 Participants
Sex: Female, Male Male	316 Participants n=5 Participants	322 Participants n=7 Participants	638 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	16 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	357 Participants n=5 Participants	369 Participants n=7 Participants	726 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	37 Participants n=5 Participants	21 Participants n=7 Participants	58 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Number of Participants n=5 Participants	1 Number of Participants n=7 Participants	1 Number of Participants n=5 Participants
Race/Ethnicity, Customized Asian	68 Number of Participants n=5 Participants	64 Number of Participants n=7 Participants	132 Number of Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	3 Number of Participants n=5 Participants	3 Number of Participants n=7 Participants	6 Number of Participants n=5 Participants
Race/Ethnicity, Customized White	307 Number of Participants n=5 Participants	320 Number of Participants n=7 Participants	627 Number of Participants n=5 Participants
Race/Ethnicity, Customized Other	4 Number of Participants n=5 Participants	6 Number of Participants n=7 Participants	10 Number of Participants n=5 Participants
Race/Ethnicity, Customized Unknown	21 Number of Participants n=5 Participants	12 Number of Participants n=7 Participants	33 Number of Participants n=5 Participants

PRIMARY outcome

Timeframe: Randomization up to first occurrence of DFS event (up to approximately 50 months)

Population: The ITT population is defined as all randomized patients, whether or not the patient received the assigned treatment (atezolizumab/observation).

DFS is defined as the time from randomization to the time of first occurrence of a DFS event. DFS events include: local (pelvic) recurrence of UC (including soft tissue and regional lymph nodes); urinary tract recurrence of UC (including all pathological stages and grades); distant metastasis of UC; or death from any cause. Tumor assessment will be performed using radiographic evaluations.

Outcome measures

Measure	Observation n=403 Participants Participants underwent observation starting on Day 1 for 16 cycles (up to 1 year).	Atezolizumab n=406 Participants Participants received intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).
Disease-Free Survival (DFS), as Assessed by Investigator	16.6 Months Interval 11.2 to 24.8	19.4 Months Interval 15.9 to 24.8

SECONDARY outcome

Timeframe: Randomization until death due to any cause (up to approximately 80 months)

Population: The ITT population is defined as all randomized patients, whether or not the patient received the assigned treatment (atezolizumab/observation).

Overall survival is defined as the time from randomization to the date of death from any cause, regardless of whether the death occurs during study treatment or following treatment discontinuation.

Outcome measures

Measure	Observation n=403 Participants Participants underwent observation starting on Day 1 for 16 cycles (up to 1 year).	Atezolizumab n=406 Participants Participants received intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).
Overall Survival (OS)	59.0 Months Interval 47.7 to Median Overall Survival not reached at the time of final analysis.	61.4 Months Interval 47.0 to Median Overall Survival not reached at the time of final analysis.

SECONDARY outcome

Timeframe: Randomization until death due to UC (up to approximately 50 months)

Population: The ITT population is defined as all randomized patients, whether or not the patient received the assigned treatment (atezolizumab/observation).

DSS is defined as the time from randomization until the date of death from UC.

Outcome measures

Measure	Observation n=403 Participants Participants underwent observation starting on Day 1 for 16 cycles (up to 1 year).	Atezolizumab n=406 Participants Participants received intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).
Disease-Specific Survival (DSS), as Assessed by Investigator	NA Months Median has not been reached.	NA Months Median has not been reached.

SECONDARY outcome

Timeframe: Randomization up to diagnosis of distant metastases or death from any cause (up to approximately 50 months)

Population: The ITT population is defined as all randomized patients, whether or not the patient received the assigned treatment (atezolizumab/observation).

DMFS is defined as the time from randomization to the date of diagnosis of distant (that is, non-locoregional) metastases or death from any cause. Tumor assessment will be performed using radiographic evaluations.

Outcome measures

Measure	Observation n=403 Participants Participants underwent observation starting on Day 1 for 16 cycles (up to 1 year).	Atezolizumab n=406 Participants Participants received intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).
Distant Metastasis-Free Survival (DMFS)	31.1 Months Interval 21.7 to 41.4	27.5 Months Interval 22.6 to Upper bound is not estimable due to insufficient number of subjects with DMFS events.

SECONDARY outcome

Timeframe: Randomization up to time of first occurrence of a NURFS event (up to approximately 50 months)

Population: The ITT population is defined as all randomized patients, whether or not the patient received the assigned treatment (atezolizumab/observation).

NURFS is defined as the time from randomization to the time of first occurrence of a NURFS event. NURFS events include: local (pelvic) recurrence of UC (including soft tissue and regional lymph nodes); distant metastasis of UC; or death from any cause. Tumor assessment will be performed using radiographic evaluations.

Outcome measures

Measure	Observation n=403 Participants Participants underwent observation starting on Day 1 for 16 cycles (up to 1 year).	Atezolizumab n=406 Participants Participants received intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).
Non-Urinary Tract Recurrence-Free Survival (NURFS)	19.5 Months Interval 12.3 to 27.7	22.1 Months Interval 17.2 to 27.6

SECONDARY outcome

Timeframe: Screening up to approximately 80 months

Population: The safety population is defined as patients who received at least one dose of atezolizumab, and all patients who did not receive any dose of atezolizumab who had at least one post-baseline safety assessment (e.g.,adverse event, lab, vital signs, ECG, etc.), regardless of their assigned treatment (atezolizumab/observation).

Percentage of participants with at least one Adverse Event.

Outcome measures

Measure	Observation n=398 Participants Participants underwent observation starting on Day 1 for 16 cycles (up to 1 year).	Atezolizumab n=390 Participants Participants received intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).
Percentage of Participants With Adverse Events (AEs)	79.1 Percentage of Participants	94.4 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline up to approximately 50 months

Population: The anti-drug antibodies (ADA)-evaluable population is defined as all patients treated with atezolizumab who have at least one post-baseline ADA result.

Percentage of participants with anti-therapeutic antibodies to atezolizumab.

Outcome measures

Measure	Observation n=375 Participants Participants underwent observation starting on Day 1 for 16 cycles (up to 1 year).	Atezolizumab Participants received intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab	29.3 Percentage of Participants	—

SECONDARY outcome

Timeframe: Day 1 of Cycle 1 up to approximately 50 months (Cycle length = 21 days)

Population: The ITT population is defined as all randomized patients, whether or not the patient received the assigned treatment (atezolizumab/observation).

The EQ-5D-5L is a generic preference-based HRQoL questionnaire that provides a single index value for health status and is used to inform pharmacoeconomic evaluations and to measure general health status. Visual analog scale (VAS) allows the patient to indicate, on a scale of 0-100, how his or her health is on the day of assessment, with 100 being the "best imaginable health state" and 0 being the "worst imaginable health state."

Outcome measures

Measure	Observation n=403 Participants Participants underwent observation starting on Day 1 for 16 cycles (up to 1 year).	Atezolizumab n=406 Participants Participants received intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).
EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale Score Cycle 1 Day 1	77.41 Score on scale Standard Deviation 15.74	78.89 Score on scale Standard Deviation 16.13
EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale Score Cycle 3 Day 1	78.64 Score on scale Standard Deviation 15.73	81.05 Score on scale Standard Deviation 14.96
EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale Score Cycle 5 Day 1	79.94 Score on scale Standard Deviation 16.32	81.95 Score on scale Standard Deviation 14.32
EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale Score Cycle 7 Day 1	80.81 Score on scale Standard Deviation 16.37	82.39 Score on scale Standard Deviation 14.43
EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale Score Cycle 9 Day 1	81.24 Score on scale Standard Deviation 15.70	82.06 Score on scale Standard Deviation 15.34
EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale Score Cycle 11 Day 1	81.39 Score on scale Standard Deviation 17.02	82.81 Score on scale Standard Deviation 14.96
EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale Score Cycle 13 Day 1	81.39 Score on scale Standard Deviation 16.99	82.59 Score on scale Standard Deviation 14.81
EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale Score Cycle 15 Day 1	82.78 Score on scale Standard Deviation 16.01	83.67 Score on scale Standard Deviation 14.47
EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale Score Treatment Discontinuation	82.68 Score on scale Standard Deviation 16.19	81.91 Score on scale Standard Deviation 15.96

SECONDARY outcome

Timeframe: Pre-dose (Hour 0) on Day 1 of Cycles 1, 2, 3, 4, every 8 cycles from Cycle 8, at treatment discontinuation, 120 days after treatment discontinuation (up to approximately 50 months))(Cycle length = 21 days)

Population: The pharmacokinetic-evaluable population is defined as all patients who received any dose of atezolizumab and who have evaluable pharmacokinetic (PK) samples.

Minimum observed serum atezolizumab concentration (Cmin) prior to infusion on Day 1 of Cycles 1, 2, 3, and 4; every 8 cycles starting on Cycle 8; at treatment discontinuation; and at 120 days after the last dose of atezolizumab.

Outcome measures

Measure	Observation n=380 Participants Participants underwent observation starting on Day 1 for 16 cycles (up to 1 year).	Atezolizumab Participants received intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).
Minimum Observed Serum Atezolizumab Concentration (Cmin) Cycle 2 Day 1	78.4 µg/mL Standard Deviation 25.2	—
Minimum Observed Serum Atezolizumab Concentration (Cmin) Cycle 3 Day 1	125 µg/mL Standard Deviation 46.0	—
Minimum Observed Serum Atezolizumab Concentration (Cmin) Cycle 4 Day 1	152 µg/mL Standard Deviation 71.1	—
Minimum Observed Serum Atezolizumab Concentration (Cmin) Cycle 8 Day 1	203 µg/mL Standard Deviation 92.0	—
Minimum Observed Serum Atezolizumab Concentration (Cmin) Cycle 16 Day 1	225 µg/mL Standard Deviation 106	—
Minimum Observed Serum Atezolizumab Concentration (Cmin) Day 120 Post Last Dose MPDL3280A	15.9 µg/mL Standard Deviation 19.5	—
Minimum Observed Serum Atezolizumab Concentration (Cmin) Study Drug or Study Phase Comp or Early Disc	164 µg/mL Standard Deviation 106	—

SECONDARY outcome

Timeframe: Day 1 of Cycle 1 (Cycle length = 21 days)

Population: The pharmacokinetic-evaluable population is defined as all patients who received any dose of atezolizumab and who have evaluable pharmacokinetic (PK) samples.

Maximum observed serum atezolizumab concentration (Cmax) after infusion on Day 1 of Cycle 1.

Outcome measures

Measure	Observation n=300 Participants Participants underwent observation starting on Day 1 for 16 cycles (up to 1 year).	Atezolizumab Participants received intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).
Maximum Observed Serum Atezolizumab Concentration (Cmax)	365 µg/mL Standard Deviation 121	—

Adverse Events

OBSERVATION

Serious events: 72 serious events

Other events: 234 other events

Deaths: 162 deaths

ATEZOLIZUMAB

Serious events: 122 serious events

Other events: 324 other events

Deaths: 171 deaths

Serious adverse events

Measure	OBSERVATION n=398 participants at risk Participants underwent observation starting on Day 1 for 16 cycles (up to 1 year).	ATEZOLIZUMAB n=390 participants at risk Participants received intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).
Blood and lymphatic system disorders Anaemia	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Cardiac disorders Atrial fibrillation	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.51% 2/390 • Number of events 2 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Cardiac disorders Bradycardia	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Cardiac disorders Cardio-respiratory arrest	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.00% 0/390 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Cardiac disorders Myocardial infarction	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Cardiac disorders Supraventricular tachycardia	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Endocrine disorders Adrenal insufficiency	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Endocrine disorders Hypophysitis	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Endocrine disorders Hypothyroidism	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Gastrointestinal disorders Abdominal pain	0.50% 2/398 • Number of events 2 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.00% 0/390 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Gastrointestinal disorders Colitis	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	1.0% 4/390 • Number of events 4 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Gastrointestinal disorders Constipation	0.50% 2/398 • Number of events 2 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.00% 0/390 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Gastrointestinal disorders Diarrhoea	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	1.3% 5/390 • Number of events 5 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Gastrointestinal disorders Enterovesical fistula	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Gastrointestinal disorders Hernial eventration	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Gastrointestinal disorders Ileus	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Gastrointestinal disorders Immune-mediated enterocolitis	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Gastrointestinal disorders Intestinal obstruction	0.50% 2/398 • Number of events 2 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	1.0% 4/390 • Number of events 5 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Gastrointestinal disorders Intestinal perforation	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.51% 2/390 • Number of events 2 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Gastrointestinal disorders Mechanical ileus	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Gastrointestinal disorders Pancreatitis acute	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Gastrointestinal disorders Proctalgia	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.00% 0/390 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Gastrointestinal disorders Proctitis	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Gastrointestinal disorders Small intestinal obstruction	0.50% 2/398 • Number of events 2 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Gastrointestinal disorders Small intestine ulcer	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Gastrointestinal disorders Vomiting	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
General disorders Asthenia	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
General disorders Death	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.77% 3/390 • Number of events 3 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
General disorders Hernia pain	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.00% 0/390 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
General disorders Hyperthermia	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
General disorders Influenza like illness	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
General disorders Lithiasis	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
General disorders Malaise	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
General disorders Pyrexia	0.75% 3/398 • Number of events 3 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	2.8% 11/390 • Number of events 11 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.51% 2/390 • Number of events 3 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Hepatobiliary disorders Bile duct stone	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Hepatobiliary disorders Cholangitis	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Hepatobiliary disorders Cholecystitis	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Hepatobiliary disorders Hepatic haematoma	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Hepatobiliary disorders Hepatitis	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Hepatobiliary disorders Liver disorder	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Immune system disorders Drug hypersensitivity	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.51% 2/390 • Number of events 2 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Immune system disorders Systemic immune activation	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.51% 2/390 • Number of events 2 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Infections and infestations Abdominal abscess	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Infections and infestations Bacteraemia	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Infections and infestations Bacterial sepsis	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Infections and infestations Cystitis	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.00% 0/390 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Infections and infestations Diabetic foot infection	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Infections and infestations Escherichia sepsis	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.00% 0/390 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Infections and infestations Febrile infection	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Infections and infestations Infection	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Infections and infestations Kidney infection	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Infections and infestations Lower respiratory tract infection	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Infections and infestations Neuroborreliosis	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Infections and infestations Osteomyelitis	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Infections and infestations Pneumonia	0.50% 2/398 • Number of events 2 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	1.0% 4/390 • Number of events 4 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Infections and infestations Pyelonephritis	2.3% 9/398 • Number of events 11 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	3.1% 12/390 • Number of events 16 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Infections and infestations Pyelonephritis acute	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 2 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Infections and infestations Pyelonephritis chronic	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Infections and infestations Renal abscess	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Infections and infestations Respiratory tract infection	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Infections and infestations Sepsis	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.77% 3/390 • Number of events 5 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Infections and infestations Septic shock	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.00% 0/390 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Infections and infestations Sinusitis	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Infections and infestations Upper respiratory tract infection	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Infections and infestations Urinary tract infection	4.8% 19/398 • Number of events 21 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	7.7% 30/390 • Number of events 41 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Infections and infestations Urinary tract infection bacterial	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Infections and infestations Urosepsis	0.75% 3/398 • Number of events 3 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Infections and infestations Vascular device infection	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Infections and infestations Wound infection	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Injury, poisoning and procedural complications Incision site impaired healing	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.51% 2/390 • Number of events 2 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Injury, poisoning and procedural complications Stoma obstruction	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Injury, poisoning and procedural complications Stomal hernia	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.00% 0/390 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Injury, poisoning and procedural complications Ureteric anastomosis complication	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.00% 0/390 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Injury, poisoning and procedural complications Urostomy complication	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.00% 0/390 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Metabolism and nutrition disorders Acidosis	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Metabolism and nutrition disorders Dehydration	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Metabolism and nutrition disorders Diabetes mellitus	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Metabolism and nutrition disorders Hypercalcaemia	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.00% 0/390 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Metabolism and nutrition disorders Hyperglycaemia	0.50% 2/398 • Number of events 2 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.51% 2/390 • Number of events 2 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.00% 0/390 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.00% 0/390 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.00% 0/390 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal squamous cell carcinoma	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.00% 0/390 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.00% 0/390 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour of ampulla of Vater	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Nervous system disorders Cerebral haemorrhage	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.00% 0/390 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Nervous system disorders Cerebrovascular accident	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Nervous system disorders Headache	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Nervous system disorders Ischaemic stroke	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.00% 0/390 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Nervous system disorders Neuropathy peripheral	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Nervous system disorders Syncope	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.00% 0/390 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Product Issues Device dislocation	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.00% 0/390 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Product Issues Device occlusion	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.00% 0/390 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Renal and urinary disorders Acute kidney injury	1.0% 4/398 • Number of events 4 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	2.1% 8/390 • Number of events 8 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Renal and urinary disorders Autoimmune nephritis	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Renal and urinary disorders Dysuria	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Renal and urinary disorders Hydronephrosis	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Renal and urinary disorders Nephritis	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Renal and urinary disorders Nephrolithiasis	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 3 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Renal and urinary disorders Renal impairment	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Renal and urinary disorders Renal injury	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Renal and urinary disorders Ureteric obstruction	0.25% 1/398 • Number of events 2 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Renal and urinary disorders Ureteric stenosis	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Renal and urinary disorders Ureterolithiasis	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Renal and urinary disorders Urinary retention	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.00% 0/390 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Renal and urinary disorders Urinary tract obstruction	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.51% 2/390 • Number of events 2 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Renal and urinary disorders Urinoma	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.00% 0/390 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Renal and urinary disorders Vesicoureteric reflux	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Reproductive system and breast disorders Female genital tract fistula	0.50% 2/398 • Number of events 2 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.00% 0/390 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.00% 0/390 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.77% 3/390 • Number of events 3 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.3% 5/398 • Number of events 5 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Skin and subcutaneous tissue disorders Rash	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Vascular disorders Arteriosclerosis	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.00% 0/390 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Vascular disorders Deep vein thrombosis	0.75% 3/398 • Number of events 3 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.00% 0/390 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Vascular disorders Embolism	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.00% 0/390 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Vascular disorders Hypertension	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.00% 0/390 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Vascular disorders Hypotension	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.00% 0/390 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Vascular disorders Lymphocele	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Vascular disorders Orthostatic hypotension	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Infections and infestations COVID-19	0.25% 1/398 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.00% 0/390 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Nervous system disorders Immune-mediated neurological disorder	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	0.26% 1/390 • Number of events 1 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.

Other adverse events

Measure	OBSERVATION n=398 participants at risk Participants underwent observation starting on Day 1 for 16 cycles (up to 1 year).	ATEZOLIZUMAB n=390 participants at risk Participants received intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).
General disorders Chills	1.8% 7/398 • Number of events 9 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	5.9% 23/390 • Number of events 25 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Investigations Blood creatinine increased	4.3% 17/398 • Number of events 20 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	9.5% 37/390 • Number of events 42 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Metabolism and nutrition disorders Decreased appetite	5.0% 20/398 • Number of events 21 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	11.5% 45/390 • Number of events 54 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Musculoskeletal and connective tissue disorders Arthralgia	6.5% 26/398 • Number of events 29 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	13.6% 53/390 • Number of events 62 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Blood and lymphatic system disorders Anaemia	8.0% 32/398 • Number of events 34 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	10.8% 42/390 • Number of events 53 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Endocrine disorders Hypothyroidism	0.00% 0/398 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	9.0% 35/390 • Number of events 38 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Gastrointestinal disorders Abdominal pain	7.3% 29/398 • Number of events 32 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	7.9% 31/390 • Number of events 39 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Gastrointestinal disorders Constipation	9.8% 39/398 • Number of events 40 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	13.1% 51/390 • Number of events 60 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Gastrointestinal disorders Diarrhoea	6.3% 25/398 • Number of events 29 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	20.8% 81/390 • Number of events 104 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Gastrointestinal disorders Nausea	5.0% 20/398 • Number of events 21 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	13.3% 52/390 • Number of events 60 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Gastrointestinal disorders Vomiting	3.5% 14/398 • Number of events 16 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	6.7% 26/390 • Number of events 34 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
General disorders Asthenia	4.0% 16/398 • Number of events 16 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	9.0% 35/390 • Number of events 41 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
General disorders Fatigue	10.8% 43/398 • Number of events 50 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	22.8% 89/390 • Number of events 118 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
General disorders Oedema peripheral	5.8% 23/398 • Number of events 26 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	8.7% 34/390 • Number of events 39 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
General disorders Pyrexia	7.5% 30/398 • Number of events 43 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	18.2% 71/390 • Number of events 90 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Infections and infestations Upper respiratory tract infection	4.5% 18/398 • Number of events 19 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	5.4% 21/390 • Number of events 27 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Infections and infestations Urinary tract infection	14.8% 59/398 • Number of events 84 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	16.2% 63/390 • Number of events 88 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Investigations Alanine aminotransferase increased	1.8% 7/398 • Number of events 8 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	6.2% 24/390 • Number of events 32 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Investigations Aspartate aminotransferase increased	1.3% 5/398 • Number of events 6 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	5.1% 20/390 • Number of events 25 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Investigations Blood alkaline phosphatase increased	2.0% 8/398 • Number of events 8 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	5.1% 20/390 • Number of events 29 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Musculoskeletal and connective tissue disorders Back pain	11.1% 44/398 • Number of events 51 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	6.7% 26/390 • Number of events 30 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Musculoskeletal and connective tissue disorders Myalgia	1.5% 6/398 • Number of events 8 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	5.4% 21/390 • Number of events 30 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Musculoskeletal and connective tissue disorders Pain in extremity	2.3% 9/398 • Number of events 9 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	5.6% 22/390 • Number of events 29 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Nervous system disorders Dizziness	2.8% 11/398 • Number of events 11 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	5.1% 20/390 • Number of events 22 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Nervous system disorders Headache	2.0% 8/398 • Number of events 8 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	9.0% 35/390 • Number of events 39 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Respiratory, thoracic and mediastinal disorders Cough	5.8% 23/398 • Number of events 23 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	12.1% 47/390 • Number of events 60 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.8% 7/398 • Number of events 7 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	6.9% 27/390 • Number of events 33 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Skin and subcutaneous tissue disorders Dry skin	0.50% 2/398 • Number of events 2 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	7.4% 29/390 • Number of events 30 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Skin and subcutaneous tissue disorders Pruritus	2.5% 10/398 • Number of events 15 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	23.6% 92/390 • Number of events 113 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
Skin and subcutaneous tissue disorders Rash	1.3% 5/398 • Number of events 6 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.	9.7% 38/390 • Number of events 48 • From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months) Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Email: genentech@druginfo.com

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