Trial Outcomes & Findings for A Study of Atezolizumab as Adjuvant Therapy in Participants With Renal Cell Carcinoma (RCC) at High Risk of Developing Metastasis Following Nephrectomy (NCT NCT03024996)

NCT ID: NCT03024996

Last Updated: 2023-08-03

Results Overview

Investigator-assessed DFS, defined as the time from randomization to death from any cause or the first documented recurrence assessed by investigator, whichever occurred first. Recurrence was defined as any of the following: Local recurrence of renal cell carcinoma (RCC), new primary RCC, or distant metastasis of RCC. Investigator-assessed DFS was analyzed similarly to the analysis of IRF-assessed DFS.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 778 participants
• Primary outcome timeframe: From baseline up to first occurence of event by investigator assessment (up to approximately 64 months)
• Results posted on: 2023-08-03

Participant Flow

5 participants were randomized but did not receive any treatment.

Participant milestones

Measure	Atezolizumab Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).	Placebo Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
Overall Study STARTED	390	388
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	390	388

Reasons for withdrawal

Measure	Atezolizumab Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).	Placebo Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
Overall Study Death	57	55
Overall Study Disease relapse	1	0
Overall Study Lost to Follow-up	5	10
Overall Study Other	3	3
Overall Study Physician Decision	0	1
Overall Study Study terminated by sponsor	303	283
Overall Study Withdrawal by Subject	21	36

Baseline Characteristics

A Study of Atezolizumab as Adjuvant Therapy in Participants With Renal Cell Carcinoma (RCC) at High Risk of Developing Metastasis Following Nephrectomy

Baseline characteristics by cohort

Measure	Atezolizumab n=390 Participants Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).	Placebo n=388 Participants Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).	Total n=778 Participants Total of all reporting groups
Age, Continuous	59.7 Years STANDARD_DEVIATION 11.3 • n=5 Participants	59.6 Years STANDARD_DEVIATION 10.7 • n=7 Participants	59.7 Years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male Female	103 Participants n=5 Participants	110 Participants n=7 Participants	213 Participants n=5 Participants
Sex: Female, Male Male	287 Participants n=5 Participants	278 Participants n=7 Participants	565 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	41 Participants n=5 Participants	38 Participants n=7 Participants	79 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	334 Participants n=5 Participants	327 Participants n=7 Participants	661 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	15 Participants n=5 Participants	23 Participants n=7 Participants	38 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	43 Participants n=5 Participants	51 Participants n=7 Participants	94 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) White	324 Participants n=5 Participants	304 Participants n=7 Participants	628 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	14 Participants n=5 Participants	22 Participants n=7 Participants	36 Participants n=5 Participants

PRIMARY outcome

Timeframe: From baseline up to first occurence of event by investigator assessment (up to approximately 64 months)

Population: The Intent-to-Treat (ITT) population was defined as all randomized participants regardless of whether the assigned study treatment was received.

Investigator-assessed DFS, defined as the time from randomization to death from any cause or the first documented recurrence assessed by investigator, whichever occurred first. Recurrence was defined as any of the following: Local recurrence of renal cell carcinoma (RCC), new primary RCC, or distant metastasis of RCC. Investigator-assessed DFS was analyzed similarly to the analysis of IRF-assessed DFS.

Outcome measures

Measure	Atezolizumab n=390 Participants Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).	Placebo n=388 Participants Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
Investigator-assessed Disease-Free Survival (DFS)	57.2 Months Interval 44.6 to NA = small number of events to calculate the upper CI limit	49.5 Months Interval 47.4 to NA = small number of events to calculate the upper CI limit

SECONDARY outcome

Timeframe: From baseline up to death due to any cause (up to approximately 64 months)

Population: The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.

OS was defined as the time from randomization to death from any cause.

Outcome measures

Measure	Atezolizumab n=390 Participants Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).	Placebo n=388 Participants Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
Overall Survival (OS)	NA Months Interval 59.8 to NA = wasn't estimable due to small number of events	NA Months NA = no events

SECONDARY outcome

Timeframe: From baseline until first occurrence of DFS event (up to approximately 64 months)

Population: The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.

Investigator assessed DFS for participants with PD-L1 expression of IC1/2/3 vs IC0, defined as the time from randomization to death from any cause or the first documented recurrence assessed by investigator, whichever occurred first. Investigator-assessed DFS was analyzed similarly to the analysis of IRF-assessed DFS. PD-L1 IC0 was defined as <1% and IC1/2/3 was defined as >=1% of tumor-infiltrating IC expressing PD-L1 as assessed by immunohistochemistry using SP142 assay. Recurrence was defined as any of the following: Local recurrence of renal cell carcinoma (RCC), new primary RCC, or distant metastasis of RCC.

Outcome measures

Measure	Atezolizumab n=232 Participants Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).	Placebo n=235 Participants Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
Investigator-assessed DFS in Participants With Tumor-Infiltrating Immune Cell (IC) 1/2/3	57.2 Months Interval 44.6 to NA = small number of events to calculate the upper CI limit	47.9 Months Interval 38.6 to NA = small number of events to calculate the upper CI limit

SECONDARY outcome

Timeframe: From baseline until first documented recurrence event (up to approximately 64 months)

Population: The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.

IRF-assessed DFS was defined as the time from randomization to death from any cause or the first documented recurrence assessed by IRF, whichever occurred first.

Outcome measures

Measure	Atezolizumab n=390 Participants Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).	Placebo n=388 Participants Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
Independent Review Facility (IRF)-Assessed DFS	NA Months Interval 54.1 to NA = wasn't estimable due to small number of events	NA Months Interval 49.4 to NA = wasn't estimable due to small number of events

SECONDARY outcome

Timeframe: From baseline until first occurrence of DFS event (up to approximately 64 months)

Population: The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.

IRF-assessed DFS was defined as the time from randomization to death from any cause or the first documented recurrence assessed by IRF, whichever occurred first. PD-L1 IC0 was defined as <1% and IC1/2/3 was defined as >=1% of tumor-infiltrating IC expressing PD-L1 as assessed by immunohistochemistry using SP142 assay.

Outcome measures

Measure	Atezolizumab n=232 Participants Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).	Placebo n=235 Participants Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
IRF-assessed DFS in Participants With Tumor-Infiltrating IC 1/2/3	NA Months NA = no events	NA Months Interval 41.4 to NA = wasn't estimable due to small number of events

SECONDARY outcome

Timeframe: From baseline until first documented recurrence event (up to approximately 64 months)

Population: The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.

IRF-assessed EFS was defined as the time from randomization to death from any cause, or the first documented recurrence in participants without baseline disease by IRF or the first documented disease progression in participants identified as having baseline disease by IRF, whichever occurred first. Disease progression was defined as either unequivocal progression of baseline disease or new unequivocal lesions.

Outcome measures

Measure	Atezolizumab n=390 Participants Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).	Placebo n=388 Participants Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
IRF-assessed Event-free Survival (EFS)	NA Months Interval 54.1 to NA = wasn't estimable due to small number of events	NA Months Interval 45.4 to NA = wasn't estimable due to small number of events

SECONDARY outcome

Timeframe: From baseline up to death due to RCC (up to approximately 64 months)

Population: The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.

Disease-specific survival was defined as the time from randomization to death from renal cell carcinoma (RCC).

Outcome measures

Measure	Atezolizumab n=390 Participants Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).	Placebo n=388 Participants Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
Disease-Specific Survival	NA Months NA = no events	NA Months NA = no events

SECONDARY outcome

Timeframe: From baseline up to date of diagnosis of distant metastases or death due to any cause (up to approximately 64 months)

Population: The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.

Distant metastasis-free survival, defined as the time from randomization to death from any cause or the date of diagnosis of distant (i.e., non-locoregional) metastases assessed by the investigator, whichever occurred first.

Outcome measures

Measure	Atezolizumab n=390 Participants Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).	Placebo n=388 Participants Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
Distant Metastasis-Free Survival	NA Months Interval 48.4 to NA = wasn't estimable due to small number of events	52.9 Months Interval 47.9 to NA = small number of events to calculate the upper CI limit

SECONDARY outcome

Timeframe: Up to 3 years

Population: The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.

IRF-assessed DFS was defined as the percentage of participants being alive and free of recurrence assessed by IRF at Year 1, 2, and 3 after randomization.

Outcome measures

Measure	Atezolizumab n=390 Participants Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).	Placebo n=388 Participants Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
Percentage of Participants Who Are Alive and IRF-assessed Recurrence Free at Year 1, 2, and 3 Year 1	81.01 Percentage of Participants	76.42 Percentage of Participants
Percentage of Participants Who Are Alive and IRF-assessed Recurrence Free at Year 1, 2, and 3 Year 2	70.40 Percentage of Participants	68.22 Percentage of Participants
Percentage of Participants Who Are Alive and IRF-assessed Recurrence Free at Year 1, 2, and 3 Year 3	65.04 Percentage of Participants	62.71 Percentage of Participants

SECONDARY outcome

Timeframe: Up to 3 years

Population: The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.

Investigator-assessed DFS rate was defined as the percentage of participants being alive and free of recurrence assessed by investigator at Year 1, 2, and 3 after randomization.

Outcome measures

Measure	Atezolizumab n=390 Participants Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).	Placebo n=388 Participants Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
Percentage of Participants Who Are Alive and Investigator-assessed Recurrence Free at Year 1, 2, and 3 Year 1	77.41 Percentage of Participants	74.12 Percentage of Participants
Percentage of Participants Who Are Alive and Investigator-assessed Recurrence Free at Year 1, 2, and 3 Year 2	67.32 Percentage of Participants	65.01 Percentage of Participants
Percentage of Participants Who Are Alive and Investigator-assessed Recurrence Free at Year 1, 2, and 3 Year 3	59.43 Percentage of Participants	59.00 Percentage of Participants

SECONDARY outcome

Timeframe: From baseline up to death due to any cause (up to approximately 71 months)

Population: The safety population included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.

An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unitended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a pharmaceutical product whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as a AEs.

Outcome measures

Measure	Atezolizumab n=390 Participants Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).	Placebo n=383 Participants Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
Percentage of Participants With Adverse Events	373 Participants	341 Participants

SECONDARY outcome

Timeframe: Predose (Hour[hr]0), 0.5 hr after end of infusion (infusion duration=1 hr) on Cycle 1 Day 1; predose (hr 0) on Day 1 of Cycles 2, 3, 4, 8; at treatment discontinuation (up to 1 year); 90-120 days after last dose (last dose = up to 1 year) (Cycle=21 days)

Population: The pharmacokinetic (PK) population included all randomized participants who received any any dose of study treatment and who had at least one measurable post-baseline PK sample available.

Outcome measures

Measure	Atezolizumab n=369 Participants Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).	Placebo Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
Maximum Serum Concentration (Cmax) of Atezolizumab	399 Micrograms per milliliter (ug/mL) Standard Deviation 138	—

SECONDARY outcome

Timeframe: Predose (Hour[hr]0), 0.5 hr after end of infusion (infusion duration=1 hr) on Cycle 1 Day 1; predose (hr 0) on Day 1 of Cycles 2, 3, 4, 8; at treatment discontinuation (up to 1 year); 90-120 days after last dose (last dose = up to 1 year) (Cycle=21 days)

Population: The PK population included all randomized participants who received any any dose of study treatment and who had at least one measurable post-baseline PK sample available.

Outcome measures

Measure	Atezolizumab n=85 Participants Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).	Placebo Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
Minimum Serum Concentration (Cmin) of Atezolizumab	34.1 ug/mL Standard Deviation 30.1	—

SECONDARY outcome

Timeframe: Predose (hr 0) on Day 1 of Cycles 1, 2, 3, 4, 8; at treatment discontinuation (up to 1 year); 90-120 days after last dose (last dose = up to 1 year) (Cycle=21 days)

Population: The immunogenicity analysis population will consist of all participants with at least one ADA assessment for atezolizumab. The post-baseline ADA evaluable population included all participants who received at least one dose of atezolizumab and with at least one post-dose ADA assessment.

Outcome measures

Measure	Atezolizumab n=390 Participants Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).	Placebo Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
Percentage of Participants With Anti-Drug Antibodies (ADA) to Atezolizumab Baseline	7 Participants	—
Percentage of Participants With Anti-Drug Antibodies (ADA) to Atezolizumab Treatment Emergent ADAs	103 Participants	—

Adverse Events

Atezolizumab

Serious events: 69 serious events

Other events: 329 other events

Deaths: 57 deaths

Placebo

Serious events: 46 serious events

Other events: 290 other events

Deaths: 55 deaths

Serious adverse events

Measure	Atezolizumab n=390 participants at risk Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).	Placebo n=383 participants at risk Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
Blood and lymphatic system disorders Anaemia	0.51% 2/390 • Number of events 2 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Blood and lymphatic system disorders Leukopenia	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Cardiac disorders Angina pectoris	0.00% 0/390 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.26% 1/383 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Cardiac disorders Atrial fibrillation	0.51% 2/390 • Number of events 2 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Cardiac disorders Atrial flutter	0.00% 0/390 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.26% 1/383 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Cardiac disorders Coronary artery occlusion	0.00% 0/390 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.26% 1/383 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Cardiac disorders Myocardial infarction	0.00% 0/390 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.26% 1/383 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Cardiac disorders Myocarditis	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Cardiac disorders Tachycardia	0.00% 0/390 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.26% 1/383 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Cardiac disorders Ventricular arrhythmia	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Ear and labyrinth disorders Vertigo	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.26% 1/383 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Endocrine disorders Adrenal insufficiency	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Endocrine disorders Basedow's disease	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Eye disorders Blindness unilateral	0.00% 0/390 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.26% 1/383 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Gastrointestinal disorders Abdominal pain	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Gastrointestinal disorders Colitis	0.77% 3/390 • Number of events 4 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Gastrointestinal disorders Diarrhoea	0.77% 3/390 • Number of events 3 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.26% 1/383 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Gastrointestinal disorders Eosinophilic colitis	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/390 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.26% 1/383 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Gastrointestinal disorders Intestinal obstruction	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.26% 1/383 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Gastrointestinal disorders Large intestine polyp	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Gastrointestinal disorders Pancreatitis	0.00% 0/390 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.26% 1/383 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/390 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.52% 2/383 • Number of events 2 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Gastrointestinal disorders Umbilical hernia	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Gastrointestinal disorders Vomiting	0.51% 2/390 • Number of events 2 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
General disorders Asthenia	0.51% 2/390 • Number of events 2 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
General disorders Death	0.00% 0/390 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.26% 1/383 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
General disorders Influenza like illness	0.51% 2/390 • Number of events 2 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
General disorders Non-cardiac chest pain	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
General disorders Polyp	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
General disorders Pyrexia	0.77% 3/390 • Number of events 3 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
General disorders Ulcer	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Hepatobiliary disorders Cholecystitis	0.00% 0/390 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.78% 3/383 • Number of events 3 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/390 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.26% 1/383 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Hepatobiliary disorders Hepatitis	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Immune system disorders Hypersensitivity	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Immune system disorders Immune-mediated adverse reaction	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Immune system disorders Systemic immune activation	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Infections and infestations Cellulitis	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.26% 1/383 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Infections and infestations Diarrhoea infectious	0.00% 0/390 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.26% 1/383 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Infections and infestations Diverticulitis	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Infections and infestations Erysipelas	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Infections and infestations Gastroenteritis viral	0.00% 0/390 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.26% 1/383 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Infections and infestations Herpes ophthalmic	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Infections and infestations Influenza	0.00% 0/390 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.26% 1/383 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Infections and infestations Lower respiratory tract infection viral	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Infections and infestations Mediastinitis	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Infections and infestations Meningitis aseptic	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Infections and infestations Oesophageal candidiasis	0.00% 0/390 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.26% 1/383 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Infections and infestations Pharyngeal abscess	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Infections and infestations Pharyngitis	0.00% 0/390 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.26% 1/383 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Infections and infestations Pneumonia	0.77% 3/390 • Number of events 3 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.52% 2/383 • Number of events 2 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Infections and infestations Salpingitis	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Infections and infestations Sepsis	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.52% 2/383 • Number of events 2 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Infections and infestations Sinusitis	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Infections and infestations Streptococcal infection	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Infections and infestations Urinary tract infection	1.0% 4/390 • Number of events 4 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.78% 3/383 • Number of events 3 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Infections and infestations Urosepsis	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Injury, poisoning and procedural complications Contusion	0.00% 0/390 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.26% 1/383 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Injury, poisoning and procedural complications Fall	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Injury, poisoning and procedural complications Infusion related reaction	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/390 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.26% 1/383 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Injury, poisoning and procedural complications Post procedural fever	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Injury, poisoning and procedural complications Upper limb fracture	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.26% 1/383 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Investigations Alanine aminotransferase increased	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Investigations Aspartate aminotransferase increased	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Metabolism and nutrition disorders Hyperglycaemia	1.3% 5/390 • Number of events 5 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.52% 2/383 • Number of events 2 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/390 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.26% 1/383 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Musculoskeletal and connective tissue disorders Arthritis	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Musculoskeletal and connective tissue disorders Flank pain	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Musculoskeletal and connective tissue disorders Muscular weakness	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Musculoskeletal and connective tissue disorders Myositis	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Musculoskeletal and connective tissue disorders Polymyositis	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.26% 1/383 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder papilloma	0.00% 0/390 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.26% 1/383 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal adenoma	0.00% 0/390 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.26% 1/383 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder cancer	0.00% 0/390 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.26% 1/383 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Nervous system disorders Aphasia	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Nervous system disorders Axonal neuropathy	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Nervous system disorders Cerebrovascular accident	0.00% 0/390 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.52% 2/383 • Number of events 2 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Nervous system disorders Dizziness	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Nervous system disorders Encephalopathy	0.00% 0/390 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.26% 1/383 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Nervous system disorders Haemorrhage intracranial	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Nervous system disorders Headache	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.52% 2/383 • Number of events 2 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Nervous system disorders Hypoaesthesia	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Nervous system disorders Neuropathy peripheral	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Nervous system disorders Paraesthesia	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Nervous system disorders Presyncope	0.00% 0/390 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.52% 2/383 • Number of events 2 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Nervous system disorders Seizure	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Nervous system disorders Syncope	0.51% 2/390 • Number of events 2 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.26% 1/383 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Nervous system disorders Tremor	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Psychiatric disorders Depression	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Renal and urinary disorders Acute kidney injury	0.00% 0/390 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.78% 3/383 • Number of events 3 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Renal and urinary disorders Tubulointerstitial nephritis	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/390 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.26% 1/383 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.77% 3/390 • Number of events 3 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.26% 1/383 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/390 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.26% 1/383 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/390 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.26% 1/383 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Skin and subcutaneous tissue disorders Dermatitis	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Skin and subcutaneous tissue disorders Dermatitis psoriasiform	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Skin and subcutaneous tissue disorders Psoriasis	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Vascular disorders Hypertension	0.00% 0/390 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.26% 1/383 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Vascular disorders Hypotension	0.00% 0/390 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.26% 1/383 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Vascular disorders Vasculitis	0.26% 1/390 • Number of events 1 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	0.00% 0/383 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.

Other adverse events

Measure	Atezolizumab n=390 participants at risk Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).	Placebo n=383 participants at risk Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
Blood and lymphatic system disorders Anaemia	6.2% 24/390 • Number of events 29 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	3.7% 14/383 • Number of events 15 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Endocrine disorders Hyperthyroidism	5.1% 20/390 • Number of events 21 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	1.0% 4/383 • Number of events 4 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Endocrine disorders Hypothyroidism	14.4% 56/390 • Number of events 62 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	3.1% 12/383 • Number of events 13 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Gastrointestinal disorders Abdominal pain	6.7% 26/390 • Number of events 31 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	6.0% 23/383 • Number of events 24 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Gastrointestinal disorders Constipation	6.7% 26/390 • Number of events 29 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	6.8% 26/383 • Number of events 28 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Gastrointestinal disorders Diarrhoea	21.8% 85/390 • Number of events 128 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	20.6% 79/383 • Number of events 125 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Gastrointestinal disorders Dry mouth	6.7% 26/390 • Number of events 29 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	1.6% 6/383 • Number of events 6 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Gastrointestinal disorders Nausea	11.8% 46/390 • Number of events 64 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	14.1% 54/383 • Number of events 77 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Gastrointestinal disorders Vomiting	4.6% 18/390 • Number of events 19 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	7.3% 28/383 • Number of events 29 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
General disorders Asthenia	9.2% 36/390 • Number of events 47 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	6.8% 26/383 • Number of events 28 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
General disorders Fatigue	28.2% 110/390 • Number of events 145 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	24.3% 93/383 • Number of events 124 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
General disorders Influenza like illness	7.4% 29/390 • Number of events 39 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	4.7% 18/383 • Number of events 27 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
General disorders Oedema peripheral	5.4% 21/390 • Number of events 26 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	4.4% 17/383 • Number of events 19 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
General disorders Pyrexia	10.5% 41/390 • Number of events 44 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	4.2% 16/383 • Number of events 32 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Infections and infestations Nasopharyngitis	5.9% 23/390 • Number of events 30 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	6.8% 26/383 • Number of events 32 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Infections and infestations Upper respiratory tract infection	8.5% 33/390 • Number of events 39 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	7.0% 27/383 • Number of events 31 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Investigations Alanine aminotransferase increased	6.7% 26/390 • Number of events 29 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	3.1% 12/383 • Number of events 15 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Investigations Blood creatinine increased	7.4% 29/390 • Number of events 36 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	7.6% 29/383 • Number of events 39 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Investigations Weight increased	2.8% 11/390 • Number of events 13 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	5.5% 21/383 • Number of events 22 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Metabolism and nutrition disorders Decreased appetite	5.4% 21/390 • Number of events 26 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	4.2% 16/383 • Number of events 16 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Musculoskeletal and connective tissue disorders Arthralgia	20.0% 78/390 • Number of events 101 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	14.9% 57/383 • Number of events 75 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Musculoskeletal and connective tissue disorders Back pain	11.0% 43/390 • Number of events 52 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	11.7% 45/383 • Number of events 55 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Musculoskeletal and connective tissue disorders Myalgia	9.0% 35/390 • Number of events 40 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	6.5% 25/383 • Number of events 39 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Musculoskeletal and connective tissue disorders Pain in extremity	4.6% 18/390 • Number of events 20 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	5.2% 20/383 • Number of events 24 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Nervous system disorders Dizziness	7.4% 29/390 • Number of events 30 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	7.6% 29/383 • Number of events 33 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Nervous system disorders Headache	13.1% 51/390 • Number of events 65 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	12.8% 49/383 • Number of events 72 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Respiratory, thoracic and mediastinal disorders Cough	13.1% 51/390 • Number of events 63 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	12.5% 48/383 • Number of events 51 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.7% 26/390 • Number of events 34 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	4.2% 16/383 • Number of events 18 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Skin and subcutaneous tissue disorders Pruritus	19.0% 74/390 • Number of events 94 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	12.5% 48/383 • Number of events 61 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Skin and subcutaneous tissue disorders Rash	11.8% 46/390 • Number of events 55 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	5.2% 20/383 • Number of events 24 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Skin and subcutaneous tissue disorders Rash maculo-papular	6.4% 25/390 • Number of events 33 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	3.7% 14/383 • Number of events 17 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Vascular disorders Hypertension	4.9% 19/390 • Number of events 20 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.	9.4% 36/383 • Number of events 41 • From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months) All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.

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