Trial Outcomes & Findings for Tislelizumab in Combination With Sitravatinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NCT NCT04921358)

NCT ID: NCT04921358

Last Updated: 2025-06-29

Results Overview

Defined as the time from randomization until the date of death due to any cause. Kaplan-Meier methodology was used to estimate the median OS.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 377 participants
• Primary outcome timeframe: Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months).
• Results posted on: 2025-06-29

Participant Flow

Participants were enrolled across multiple study centers in China and Australia. The first participant was dosed on July 27th, 2021, and the last participant completed the study on December 20th, 2023. A decision to terminate the study was made on September 25th, 2023.

Patients were randomized in a 1:1 ratio to one of two treatment groups.

Participant milestones

Measure	Tislelizumab + Sitravatinib Participants received 200 mg of intravenous tislelizumab every 3 weeks, combined with 100 mg of oral sitravatinib daily.	Docetaxel Participants received 75 mg/m² of intravenous docetaxel every 3 weeks.
Overall Study STARTED	187	190
Overall Study Treated	186	177
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	187	190

Reasons for withdrawal

Measure	Tislelizumab + Sitravatinib Participants received 200 mg of intravenous tislelizumab every 3 weeks, combined with 100 mg of oral sitravatinib daily.	Docetaxel Participants received 75 mg/m² of intravenous docetaxel every 3 weeks.
Overall Study Withdrawal by Subject	6	13
Overall Study Lost to Follow-up	3	6
Overall Study Study Terminated by Sponsor	86	89
Overall Study Death	92	82

Baseline Characteristics

Tislelizumab in Combination With Sitravatinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Measure	Tislelizumab + Sitravatinib n=187 Participants Participants received 200 mg of intravenous tislelizumab every 3 weeks, combined with 100 mg of oral sitravatinib daily.	Docetaxel n=190 Participants Participants received 75 mg/m² of intravenous docetaxel every 3 weeks.	Total n=377 Participants Total of all reporting groups
Age, Continuous	61.2 Years STANDARD_DEVIATION 8.43 • n=5 Participants	61.3 Years STANDARD_DEVIATION 8.77 • n=7 Participants	61.3 Years STANDARD_DEVIATION 8.60 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	39 Participants n=7 Participants	73 Participants n=5 Participants
Sex: Female, Male Male	153 Participants n=5 Participants	151 Participants n=7 Participants	304 Participants n=5 Participants
Race/Ethnicity, Customized Asian	175 Participants n=5 Participants	177 Participants n=7 Participants	352 Participants n=5 Participants
Race/Ethnicity, Customized White	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Region of Enrollment China	174 participants n=5 Participants	175 participants n=7 Participants	349 participants n=5 Participants
Region of Enrollment Australia	13 participants n=5 Participants	15 participants n=7 Participants	28 participants n=5 Participants
Histology Squamous	96 Participants n=5 Participants	97 Participants n=7 Participants	193 Participants n=5 Participants
Histology Non-squamous	91 Participants n=5 Participants	93 Participants n=7 Participants	184 Participants n=5 Participants
PD-L1 Expression Status >= 1% Tumor Cells	71 Participants n=5 Participants	71 Participants n=7 Participants	142 Participants n=5 Participants
PD-L1 Expression Status < 1% Tumor Cells	116 Participants n=5 Participants	119 Participants n=7 Participants	235 Participants n=5 Participants

PRIMARY outcome

Timeframe: Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months).

Population: The Intent-to-Treat (ITT) analysis set consists of all participants who were randomized to a treatment arm.

Defined as the time from randomization until the date of death due to any cause. Kaplan-Meier methodology was used to estimate the median OS.

Outcome measures

Measure	Tislelizumab + Sitravatinib n=187 Participants Participants received 200 mg of intravenous tislelizumab every 3 weeks, combined with 100 mg of oral sitravatinib daily.	Docetaxel n=190 Participants Participants received 75 mg/m² of intravenous docetaxel every 3 weeks.
Overall Survival (OS)	11.5 Months Interval 9.4 to 14.6	11.4 Months Interval 9.9 to 15.0

PRIMARY outcome

Timeframe: Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months).

Population: ITT Analysis Set

Defined as the time from randomization until first documentation of disease progression as assessed by the IRC based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death from any cause, whichever occured first. Kaplan-Meier methodology was used to estimate the median PFS.

Outcome measures

Measure	Tislelizumab + Sitravatinib n=187 Participants Participants received 200 mg of intravenous tislelizumab every 3 weeks, combined with 100 mg of oral sitravatinib daily.	Docetaxel n=190 Participants Participants received 75 mg/m² of intravenous docetaxel every 3 weeks.
Progression Free Survival (PFS) as Assessed by the Independent Review Committee (IRC)	4.4 Months Interval 4.0 to 5.7	2.9 Months Interval 2.6 to 4.2

SECONDARY outcome

Timeframe: Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months).

Population: ITT Analysis Set

Defined as the time from randomization until first documentation of disease progression as determined by the investigator based on RECIST v1.1, or death from any cause, whichever occured first. Kaplan-Meier methodology was used to estimate the median PFS.

Outcome measures

Measure	Tislelizumab + Sitravatinib n=187 Participants Participants received 200 mg of intravenous tislelizumab every 3 weeks, combined with 100 mg of oral sitravatinib daily.	Docetaxel n=190 Participants Participants received 75 mg/m² of intravenous docetaxel every 3 weeks.
Progression Free Survival (PFS) as Assessed by the Investigator	4.4 Months Interval 4.0 to 5.6	2.9 Months Interval 2.6 to 4.1

SECONDARY outcome

Timeframe: Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months).

Population: ITT Analysis Set

Defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) as assessed by the IRC per RECIST v1.1.

Outcome measures

Measure	Tislelizumab + Sitravatinib n=187 Participants Participants received 200 mg of intravenous tislelizumab every 3 weeks, combined with 100 mg of oral sitravatinib daily.	Docetaxel n=190 Participants Participants received 75 mg/m² of intravenous docetaxel every 3 weeks.
Overall Response Rate (ORR)	12.3 percentage of participants Interval 8.0 to 17.9	12.6 percentage of participants Interval 8.3 to 18.2

SECONDARY outcome

Timeframe: Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months).

Population: ITT Analysis Set. Only participants with best overall response of complete response or partial response confirmed per RECIST v1.1 were included in the analysis, and percentages were based on the number of responders.

Defined as the time from the first occurrence of a documented objective response to the time of the first occurrence of disease progression, as determined by the IRC based on RECIST v1.1, or death from any cause, whichever occurs first.

Outcome measures

Measure	Tislelizumab + Sitravatinib n=23 Participants Participants received 200 mg of intravenous tislelizumab every 3 weeks, combined with 100 mg of oral sitravatinib daily.	Docetaxel n=24 Participants Participants received 75 mg/m² of intravenous docetaxel every 3 weeks.
Duration of Response (DOR)	6.0 months Interval 3.2 to 8.5	NA months Interval 5.4 to Not estimable due to insufficient number of participants with events

SECONDARY outcome

Timeframe: Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months).

Population: ITT Analysis Set.

Defined as the percentage of participants whose best overall response (BOR) is complete response, partial response, or stable disease per RECIST v1.1.

Outcome measures

Measure	Tislelizumab + Sitravatinib n=187 Participants Participants received 200 mg of intravenous tislelizumab every 3 weeks, combined with 100 mg of oral sitravatinib daily.	Docetaxel n=190 Participants Participants received 75 mg/m² of intravenous docetaxel every 3 weeks.
Disease Control Rate (DCR)	69.5 percentage of participants Interval 62.4 to 76.0	53.7 percentage of participants Interval 46.3 to 60.9

SECONDARY outcome

Timeframe: Baseline and Cycle 5 Day 1 (Week 12) and Cycle 7 Day 1 (Week 18)

Population: Participants in the ITT Analysis Set with available at Baseline and each postbaseline visit

The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and 2 global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. Higher scores in GHS and functional scales indicate better quality of life.

Outcome measures

Measure	Tislelizumab + Sitravatinib n=105 Participants Participants received 200 mg of intravenous tislelizumab every 3 weeks, combined with 100 mg of oral sitravatinib daily.	Docetaxel n=69 Participants Participants received 75 mg/m² of intravenous docetaxel every 3 weeks.
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (GHS) and Physical Functioning Scores Global Health Status at Cycle 7	-6.1 score on a scale Standard Deviation 15.86	-3.4 score on a scale Standard Deviation 17.25
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (GHS) and Physical Functioning Scores Physical Functioning at Cycle 7	-2.8 score on a scale Standard Deviation 12.30	-3.1 score on a scale Standard Deviation 16.98
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (GHS) and Physical Functioning Scores Global Health Status at Cycle 5	-5.5 score on a scale Standard Deviation 16.05	-3.0 score on a scale Standard Deviation 18.69
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (GHS) and Physical Functioning Scores Physical Functioning at Cycle 5	-4.1 score on a scale Standard Deviation 12.76	-5.1 score on a scale Standard Deviation 15.89

SECONDARY outcome

Timeframe: Baseline and Cycle 5 Day 1 (Week 12) and Cycle 7 Day 1 (Week 18)

Population: Participants in the ITT Analysis Set with available data at Baseline and each postbaseline visit

The EORTC QLQ-LC13 is the lung cancer module of the QLQ-C30 and measures lung cancer-specific disease and treatment symptoms. It includes 13 questions about specific symptoms in which participants respond based on a 4-point scale, where 1 is "not at all" and 4 is "very much". Raw scores are transformed into a 0 to 100 scale via linear transformation. Lower scores indicate an improvement in symptoms.

Outcome measures

Measure	Tislelizumab + Sitravatinib n=105 Participants Participants received 200 mg of intravenous tislelizumab every 3 weeks, combined with 100 mg of oral sitravatinib daily.	Docetaxel n=69 Participants Participants received 75 mg/m² of intravenous docetaxel every 3 weeks.
Change From Baseline in EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) Coughing, Dyspnoea, and Chest Pain Scales Coughing at Cycle 7	-5.2 score on a scale Standard Deviation 25.08	-1.3 score on a scale Standard Deviation 29.49
Change From Baseline in EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) Coughing, Dyspnoea, and Chest Pain Scales Chest Pain at Cycle 7	-2.4 score on a scale Standard Deviation 22.43	-1.3 score on a scale Standard Deviation 16.12
Change From Baseline in EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) Coughing, Dyspnoea, and Chest Pain Scales Coughing at Cycle 5	1.6 score on a scale Standard Deviation 30.09	-2.4 score on a scale Standard Deviation 27.61
Change From Baseline in EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) Coughing, Dyspnoea, and Chest Pain Scales Dyspnoea at Cycle 5	2.6 score on a scale Standard Deviation 19.09	4.5 score on a scale Standard Deviation 16.76
Change From Baseline in EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) Coughing, Dyspnoea, and Chest Pain Scales Dyspnoea at Cycle 7	-0.9 score on a scale Standard Deviation 14.66	2.1 score on a scale Standard Deviation 14.43
Change From Baseline in EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) Coughing, Dyspnoea, and Chest Pain Scales Chest Pain at Cycle 5	-0.6 score on a scale Standard Deviation 24.45	-0.5 score on a scale Standard Deviation 20.21

SECONDARY outcome

Timeframe: Baseline and Cycle 5 Day 1 (Week 12) and Cycle 7 Day 1 (Week 18)

Population: Participants in the ITT Analysis Set with available at Baseline and each postbaseline visit

The EQ-5D-5L comprises a descriptive module that includes five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression and a Visual Analogue Scale. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The VAS records a participant's self-rated health on a vertical scale from 0 to 100, where 0 is 'the worst health you can imagine and 100 is 'the best health you can imagine'. A higher score indicates better health outcomes.

Outcome measures

Measure	Tislelizumab + Sitravatinib n=105 Participants Participants received 200 mg of intravenous tislelizumab every 3 weeks, combined with 100 mg of oral sitravatinib daily.	Docetaxel n=69 Participants Participants received 75 mg/m² of intravenous docetaxel every 3 weeks.
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D-5L) Visual Analogue Scale (VAS) Cycle 7	-5.9 score on a scale Standard Deviation 12.31	-3.2 score on a scale Standard Deviation 12.60
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D-5L) Visual Analogue Scale (VAS) Cycle 5	-6.1 score on a scale Standard Deviation 14.27	-3.5 score on a scale Standard Deviation 13.76

SECONDARY outcome

Timeframe: From the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2).

Population: The Safety analysis set includes all participants who were randomized and received any dose of any study drug

Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0

Outcome measures

Measure	Tislelizumab + Sitravatinib n=186 Participants Participants received 200 mg of intravenous tislelizumab every 3 weeks, combined with 100 mg of oral sitravatinib daily.	Docetaxel n=177 Participants Participants received 75 mg/m² of intravenous docetaxel every 3 weeks.
Number of Participants With Adverse Events TEAEs	183 Participants	162 Participants
Number of Participants With Adverse Events SAEs	83 Participants	66 Participants

Adverse Events

Tislelizumab + Sitravatinib

Serious events: 83 serious events

Other events: 181 other events

Deaths: 92 deaths

Docetaxel

Serious events: 66 serious events

Other events: 150 other events

Deaths: 82 deaths

Serious adverse events

Measure	Tislelizumab + Sitravatinib n=186 participants at risk Participants received 200 mg of intravenous tislelizumab every 3 weeks, combined with 100 mg of oral sitravatinib daily.	Docetaxel n=177 participants at risk Participants received 75 mg/m² of intravenous docetaxel every 3 weeks.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/186 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	4.0% 7/177 • Number of events 7 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Blood and lymphatic system disorders Leukopenia	0.00% 0/186 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	1.1% 2/177 • Number of events 2 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Blood and lymphatic system disorders Lymphadenitis	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Blood and lymphatic system disorders Neutropenia	0.00% 0/186 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	4.5% 8/177 • Number of events 9 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Blood and lymphatic system disorders Splenic infarction	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/186 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.56% 1/177 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Cardiac disorders Atrial fibrillation	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Cardiac disorders Cardiac failure	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Cardiac disorders Cardiac failure acute	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Cardiac disorders Cardiogenic shock	0.00% 0/186 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.56% 1/177 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Cardiac disorders Myocardial infarction	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Cardiac disorders Supraventricular tachycardia	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Endocrine disorders Adrenal insufficiency	1.1% 2/186 • Number of events 2 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Endocrine disorders Immune-mediated hypophysitis	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Abdominal distension	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Abdominal pain	1.1% 2/186 • Number of events 2 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Abdominal pain upper	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Ascites	0.54% 1/186 • Number of events 2 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Colitis	0.00% 0/186 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.56% 1/177 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Constipation	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Diarrhoea	1.1% 2/186 • Number of events 2 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	1.1% 2/177 • Number of events 2 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Dysphagia	1.1% 2/186 • Number of events 2 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.56% 1/177 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Gastrointestinal perforation	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Immune-mediated enterocolitis	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Intestinal obstruction	1.1% 2/186 • Number of events 2 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Oesophageal fistula	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Oesophageal perforation	0.00% 0/186 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.56% 1/177 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Pancreatitis	1.6% 3/186 • Number of events 3 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/186 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.56% 1/177 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
General disorders Chest discomfort	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.56% 1/177 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
General disorders Death	3.2% 6/186 • Number of events 6 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.56% 1/177 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
General disorders Fatigue	1.6% 3/186 • Number of events 3 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
General disorders General physical health deterioration	2.2% 4/186 • Number of events 4 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	1.1% 2/177 • Number of events 2 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
General disorders Malaise	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
General disorders Multiple organ dysfunction syndrome	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
General disorders Pyrexia	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	1.1% 2/177 • Number of events 2 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Hepatobiliary disorders Drug-induced liver injury	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Hepatobiliary disorders Hepatic function abnormal	1.6% 3/186 • Number of events 3 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Hepatobiliary disorders Immune-mediated hepatitis	2.2% 4/186 • Number of events 4 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations Appendicitis	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations Biliary tract infection	0.54% 1/186 • Number of events 2 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations COVID-19	1.1% 2/186 • Number of events 4 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	1.1% 2/177 • Number of events 2 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations COVID-19 pneumonia	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations Febrile infection	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations Gastroenteritis	1.1% 2/186 • Number of events 2 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations Herpes zoster	0.00% 0/186 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.56% 1/177 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations Infection	0.00% 0/186 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.56% 1/177 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations Joint abscess	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations Lower respiratory tract infection	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations Pharyngitis	1.1% 2/186 • Number of events 2 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations Pneumonia	8.6% 16/186 • Number of events 16 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	9.6% 17/177 • Number of events 19 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations Scrotal infection	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations Sepsis	0.00% 0/186 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.56% 1/177 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Injury, poisoning and procedural complications Radiation pneumonitis	0.00% 0/186 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.56% 1/177 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Alanine aminotransferase increased	1.6% 3/186 • Number of events 3 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	1.1% 2/177 • Number of events 2 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Aspartate aminotransferase increased	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.56% 1/177 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Blood bilirubin increased	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Electrocardiogram QT prolonged	0.00% 0/186 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.56% 1/177 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Neutrophil count decreased	0.00% 0/186 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	4.5% 8/177 • Number of events 8 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Platelet count decreased	1.1% 2/186 • Number of events 2 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.56% 1/177 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Investigations SARS-CoV-2 test positive	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Investigations White blood cell count decreased	0.00% 0/186 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	4.5% 8/177 • Number of events 8 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Metabolism and nutrition disorders Decreased appetite	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.56% 1/177 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/186 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.56% 1/177 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Metabolism and nutrition disorders Hypoalbuminaemia	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Metabolism and nutrition disorders Hypoglycaemia	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Metabolism and nutrition disorders Hypokalaemia	0.54% 1/186 • Number of events 2 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Metabolism and nutrition disorders Hyponatraemia	1.6% 3/186 • Number of events 3 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Metabolism and nutrition disorders Hypoproteinaemia	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Musculoskeletal and connective tissue disorders Bone pain	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.56% 1/177 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Musculoskeletal and connective tissue disorders Gouty arthritis	0.00% 0/186 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.56% 1/177 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Musculoskeletal and connective tissue disorders Immune-mediated myositis	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/186 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.56% 1/177 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/186 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.56% 1/177 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/186 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.56% 1/177 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/186 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	1.1% 2/177 • Number of events 2 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphangiosis carcinomatosa	0.00% 0/186 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.56% 1/177 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	1.1% 2/186 • Number of events 2 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pericardial effusion malignant	0.00% 0/186 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.56% 1/177 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Nervous system disorders Migraine	0.00% 0/186 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.56% 1/177 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Nervous system disorders Transient ischaemic attack	0.00% 0/186 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.56% 1/177 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Psychiatric disorders Delirium	0.00% 0/186 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.56% 1/177 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Renal and urinary disorders Acute kidney injury	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Renal and urinary disorders Immune-mediated nephritis	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Renal and urinary disorders Renal failure	0.00% 0/186 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.56% 1/177 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Respiratory, thoracic and mediastinal disorders Bronchopleural fistula	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.1% 2/186 • Number of events 2 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.56% 1/177 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Respiratory, thoracic and mediastinal disorders Haemoptysis	2.7% 5/186 • Number of events 5 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.56% 1/177 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Respiratory, thoracic and mediastinal disorders Immune-mediated lung disease	1.6% 3/186 • Number of events 3 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.56% 1/177 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	3.4% 6/177 • Number of events 6 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.2% 4/186 • Number of events 4 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	1.7% 3/177 • Number of events 3 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.56% 1/177 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.6% 3/186 • Number of events 3 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.56% 1/177 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary infarction	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.1% 2/186 • Number of events 2 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.56% 1/177 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Skin and subcutaneous tissue disorders Dermatitis allergic	1.1% 2/186 • Number of events 2 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Vascular disorders Aortic dissection	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Vascular disorders Hypotension	0.00% 0/186 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	1.1% 2/177 • Number of events 2 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Vascular disorders Shock	0.00% 0/186 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.56% 1/177 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Vascular disorders Varicose vein	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Vascular disorders Venous thrombosis limb	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.

Other adverse events

Measure	Tislelizumab + Sitravatinib n=186 participants at risk Participants received 200 mg of intravenous tislelizumab every 3 weeks, combined with 100 mg of oral sitravatinib daily.	Docetaxel n=177 participants at risk Participants received 75 mg/m² of intravenous docetaxel every 3 weeks.
Blood and lymphatic system disorders Anaemia	32.8% 61/186 • Number of events 85 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	47.5% 84/177 • Number of events 163 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Blood and lymphatic system disorders Leukopenia	0.00% 0/186 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	5.1% 9/177 • Number of events 18 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Blood and lymphatic system disorders Neutropenia	1.1% 2/186 • Number of events 2 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	6.2% 11/177 • Number of events 18 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Blood and lymphatic system disorders Thrombocytopenia	4.3% 8/186 • Number of events 11 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	1.1% 2/177 • Number of events 2 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Cardiac disorders Sinus bradycardia	4.3% 8/186 • Number of events 12 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Cardiac disorders Sinus tachycardia	3.8% 7/186 • Number of events 10 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	4.0% 7/177 • Number of events 11 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Endocrine disorders Hypothyroidism	24.7% 46/186 • Number of events 54 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Abdominal distension	3.2% 6/186 • Number of events 7 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	1.7% 3/177 • Number of events 3 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Abdominal pain	7.5% 14/186 • Number of events 24 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	4.5% 8/177 • Number of events 14 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Abdominal pain upper	9.7% 18/186 • Number of events 23 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	1.7% 3/177 • Number of events 3 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Constipation	16.1% 30/186 • Number of events 33 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	14.7% 26/177 • Number of events 43 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Diarrhoea	44.1% 82/186 • Number of events 191 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	13.6% 24/177 • Number of events 37 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Dry mouth	3.2% 6/186 • Number of events 7 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.56% 1/177 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Mouth ulceration	3.2% 6/186 • Number of events 7 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	4.0% 7/177 • Number of events 8 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Nausea	15.6% 29/186 • Number of events 39 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	14.1% 25/177 • Number of events 40 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Stomatitis	6.5% 12/186 • Number of events 13 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	2.8% 5/177 • Number of events 6 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Vomiting	16.7% 31/186 • Number of events 45 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	10.7% 19/177 • Number of events 27 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
General disorders Asthenia	8.1% 15/186 • Number of events 16 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	8.5% 15/177 • Number of events 16 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
General disorders Chest pain	4.3% 8/186 • Number of events 9 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.56% 1/177 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
General disorders Fatigue	9.1% 17/186 • Number of events 18 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	9.6% 17/177 • Number of events 19 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
General disorders Malaise	2.7% 5/186 • Number of events 5 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	5.1% 9/177 • Number of events 12 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
General disorders Non-cardiac chest pain	1.6% 3/186 • Number of events 3 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	3.4% 6/177 • Number of events 6 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
General disorders Oedema peripheral	4.8% 9/186 • Number of events 10 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	3.4% 6/177 • Number of events 6 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
General disorders Pain	1.6% 3/186 • Number of events 3 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	3.4% 6/177 • Number of events 8 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
General disorders Pyrexia	9.7% 18/186 • Number of events 23 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	5.6% 10/177 • Number of events 19 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations COVID-19	5.4% 10/186 • Number of events 15 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	4.5% 8/177 • Number of events 17 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations Pneumonia	5.4% 10/186 • Number of events 11 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	4.5% 8/177 • Number of events 8 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations Upper respiratory tract infection	4.8% 9/186 • Number of events 11 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	3.4% 6/177 • Number of events 7 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations Urinary tract infection	3.8% 7/186 • Number of events 9 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	1.1% 2/177 • Number of events 2 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Alanine aminotransferase increased	51.6% 96/186 • Number of events 168 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	8.5% 15/177 • Number of events 15 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Alpha hydroxybutyrate dehydrogenase increased	7.5% 14/186 • Number of events 21 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Aspartate aminotransferase increased	59.7% 111/186 • Number of events 195 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	9.6% 17/177 • Number of events 21 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Bilirubin conjugated increased	3.2% 6/186 • Number of events 8 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	2.8% 5/177 • Number of events 6 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Blood alkaline phosphatase increased	14.0% 26/186 • Number of events 37 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	5.6% 10/177 • Number of events 15 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Blood bilirubin increased	6.5% 12/186 • Number of events 18 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	3.4% 6/177 • Number of events 12 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Blood creatine phosphokinase MB increased	39.8% 74/186 • Number of events 107 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	1.7% 3/177 • Number of events 3 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Blood creatine phosphokinase increased	12.9% 24/186 • Number of events 32 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	3.4% 6/177 • Number of events 7 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Blood creatinine increased	10.8% 20/186 • Number of events 29 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	4.5% 8/177 • Number of events 8 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Blood lactate dehydrogenase increased	22.0% 41/186 • Number of events 74 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	4.5% 8/177 • Number of events 9 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Blood pressure increased	3.8% 7/186 • Number of events 11 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	1.1% 2/177 • Number of events 3 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Blood thyroid stimulating hormone increased	10.8% 20/186 • Number of events 20 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.56% 1/177 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Blood urea increased	3.2% 6/186 • Number of events 15 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	1.1% 2/177 • Number of events 3 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Blood uric acid increased	3.2% 6/186 • Number of events 16 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.56% 1/177 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Investigations C-reactive protein increased	2.7% 5/186 • Number of events 6 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	3.4% 6/177 • Number of events 6 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Electrocardiogram QT prolonged	3.8% 7/186 • Number of events 10 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.56% 1/177 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Gamma-glutamyltransferase increased	14.5% 27/186 • Number of events 41 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	7.3% 13/177 • Number of events 16 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Lymphocyte count decreased	4.8% 9/186 • Number of events 13 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	10.7% 19/177 • Number of events 54 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Neutrophil count decreased	5.4% 10/186 • Number of events 12 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	30.5% 54/177 • Number of events 162 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Neutrophil count increased	3.2% 6/186 • Number of events 12 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	2.3% 4/177 • Number of events 5 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Platelet count decreased	19.4% 36/186 • Number of events 58 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	12.4% 22/177 • Number of events 47 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Protein urine present	7.5% 14/186 • Number of events 19 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Investigations SARS-CoV-2 test positive	12.4% 23/186 • Number of events 26 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	5.6% 10/177 • Number of events 11 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Weight decreased	29.0% 54/186 • Number of events 65 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	8.5% 15/177 • Number of events 17 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Investigations White blood cell count decreased	5.9% 11/186 • Number of events 17 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	35.0% 62/177 • Number of events 201 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Investigations White blood cells urine positive	3.2% 6/186 • Number of events 6 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	1.1% 2/177 • Number of events 4 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Metabolism and nutrition disorders Decreased appetite	28.5% 53/186 • Number of events 62 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	16.4% 29/177 • Number of events 33 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Metabolism and nutrition disorders Hypercholesterolaemia	7.0% 13/186 • Number of events 17 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	2.8% 5/177 • Number of events 6 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Metabolism and nutrition disorders Hyperglycaemia	8.1% 15/186 • Number of events 22 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	10.2% 18/177 • Number of events 24 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Metabolism and nutrition disorders Hyperlipidaemia	3.8% 7/186 • Number of events 10 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	1.1% 2/177 • Number of events 2 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Metabolism and nutrition disorders Hypertriglyceridaemia	10.2% 19/186 • Number of events 35 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	2.8% 5/177 • Number of events 8 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Metabolism and nutrition disorders Hyperuricaemia	10.2% 19/186 • Number of events 39 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	4.5% 8/177 • Number of events 14 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Metabolism and nutrition disorders Hypoalbuminaemia	30.6% 57/186 • Number of events 85 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	23.2% 41/177 • Number of events 60 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Metabolism and nutrition disorders Hypocalcaemia	14.5% 27/186 • Number of events 40 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	7.3% 13/177 • Number of events 31 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Metabolism and nutrition disorders Hypochloraemia	4.8% 9/186 • Number of events 13 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	1.7% 3/177 • Number of events 4 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Metabolism and nutrition disorders Hypokalaemia	18.8% 35/186 • Number of events 53 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	8.5% 15/177 • Number of events 28 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Metabolism and nutrition disorders Hypomagnesaemia	3.8% 7/186 • Number of events 14 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	1.7% 3/177 • Number of events 5 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Metabolism and nutrition disorders Hyponatraemia	23.1% 43/186 • Number of events 72 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	10.2% 18/177 • Number of events 22 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Metabolism and nutrition disorders Hypophosphataemia	4.8% 9/186 • Number of events 11 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	1.7% 3/177 • Number of events 9 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Metabolism and nutrition disorders Hypoproteinaemia	3.2% 6/186 • Number of events 6 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	1.7% 3/177 • Number of events 3 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	3.2% 6/186 • Number of events 8 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	5.6% 10/177 • Number of events 10 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Musculoskeletal and connective tissue disorders Back pain	6.5% 12/186 • Number of events 16 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	4.0% 7/177 • Number of events 10 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	4.8% 9/186 • Number of events 9 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	6.2% 11/177 • Number of events 11 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Nervous system disorders Headache	4.8% 9/186 • Number of events 10 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	4.5% 8/177 • Number of events 8 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Nervous system disorders Hypoaesthesia	2.2% 4/186 • Number of events 4 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	4.0% 7/177 • Number of events 10 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Nervous system disorders Peripheral sensory neuropathy	0.54% 1/186 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	5.1% 9/177 • Number of events 10 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Psychiatric disorders Insomnia	10.8% 20/186 • Number of events 25 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	7.9% 14/177 • Number of events 15 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Renal and urinary disorders Haematuria	7.5% 14/186 • Number of events 18 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	2.3% 4/177 • Number of events 14 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Renal and urinary disorders Proteinuria	18.3% 34/186 • Number of events 55 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	7.3% 13/177 • Number of events 18 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Respiratory, thoracic and mediastinal disorders Cough	14.0% 26/186 • Number of events 29 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	15.8% 28/177 • Number of events 31 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Respiratory, thoracic and mediastinal disorders Dysphonia	13.4% 25/186 • Number of events 26 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.0% 13/186 • Number of events 13 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	6.8% 12/177 • Number of events 12 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Respiratory, thoracic and mediastinal disorders Haemoptysis	13.4% 25/186 • Number of events 33 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	10.2% 18/177 • Number of events 20 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.4% 10/186 • Number of events 12 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	2.3% 4/177 • Number of events 4 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Respiratory, thoracic and mediastinal disorders Productive cough	8.1% 15/186 • Number of events 15 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	5.1% 9/177 • Number of events 9 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Skin and subcutaneous tissue disorders Alopecia	2.7% 5/186 • Number of events 5 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	33.3% 59/177 • Number of events 60 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	36.0% 67/186 • Number of events 76 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/177 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Skin and subcutaneous tissue disorders Pruritus	4.3% 8/186 • Number of events 8 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	0.56% 1/177 • Number of events 1 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Skin and subcutaneous tissue disorders Rash	17.2% 32/186 • Number of events 41 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	5.6% 10/177 • Number of events 11 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
Vascular disorders Hypertension	30.1% 56/186 • Number of events 65 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.	3.4% 6/177 • Number of events 10 • All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2). All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.

Additional Information

Study Director

BeiGene

Phone: 1-877-828-5568

Email: clinicaltrials@beigene.com

Results disclosure agreements

• Principal investigator is a sponsor employee BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information \& may request a further delay to protect its IP rights.
• Publication restrictions are in place

Restriction type: OTHER