Trial Outcomes & Findings for A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer (NCT NCT03280563)

Last Updated: 2025-11-10

Results Overview

Objective response rate (ORR) was defined as the percentage of participants with an objective response of complete response (CR) or partial response (PR) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). CR was defined as the disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) that have a reduction in short axis to \< 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD, in the absence of CR. Participants with missing or no response assessments were classified as non-responders. Percentages have been rounded off to the nearest whole number.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

144 participants

Primary outcome timeframe

Up to 50.4 months

Results posted on

2025-11-10

Participant Flow

A total of 144 participants with inoperable locally advanced or metastatic hormone receptor-positive (HR+) human epidermal growth factor receptor 2 negative (HER2-) breast cancer took part in the study at 26 investigative sites across the United States of America and South Korea from 22 December 2017 to 26 September 2024. The study is considered "Completed" because all the pre-planned study activities and analyses have been performed.

The study consisted of two stages: Stage 1: participants were randomized to either the control arm (fulvestrant) or the experimental arms. Stage 2: participants from Stage 1 who experienced unacceptable toxicity, disease progression (PD), or loss of clinical benefit received treatment in Stage 2. Stage 1 participants who did not enter Stage 2 and Stage 2 participants who completed treatment entered the long-term survival follow-up.

Participant milestones

Participant milestones
Measure	Fulvestrant Control Participants received fulvestrant, 500 milligrams (mg), as an intramuscular (IM) injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter until unacceptable toxicity or PD (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab Participants received fulvestrant (fulv), 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab (atezo) 840 mg as an intravenous (IV) infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab + Ipatasertib Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and ipatasertib (ipat), 400 mg, orally (PO), once a day (QD), on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Atezolizumab + Ipatasertib Participants received atezolizumab, 840 mg as an IV infusion on Days 1 and 15 of each cycle along with ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Atezolizumab + Entinostat Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with entinostat (entino), 5 mg, PO, once a week on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab + Abemaciclib Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and abemaciclib (abem), 150 mg, PO, twice daily (BID) until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Fulvestrant Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and bevacizumab, 10 milligrams per kilogram (mg /kg), as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Exemestane Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and exemestane, 25 mg, PO, QD during each cycle until unacceptable toxicity, or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Tamoxifen Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and tamoxifen, 20 mg, PO, QD during each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 1 STARTED	25	31	27	6	15	40	0	0	0
Stage 1 Safety-evaluable (SE) Population	20	30	26	6	15	39	0	0	0
Stage 1 COMPLETED	18	28	24	6	15	33	0	0	0
Stage 1 NOT COMPLETED	7	3	3	0	0	7	0	0	0
Stage 2 STARTED	0	0	0	0	0	0	13	4	3
Stage 2 SE Population	0	0	0	0	0	0	13	4	3
Stage 2 COMPLETED	0	0	0	0	0	0	11	3	3
Stage 2 NOT COMPLETED	0	0	0	0	0	0	2	1	0
Long-term Survival Follow-up STARTED	15	25	20	3	9	32	11	3	3
Long-term Survival Follow-up COMPLETED	0	0	0	0	0	0	0	0	0
Long-term Survival Follow-up NOT COMPLETED	15	25	20	3	9	32	11	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Fulvestrant Control Participants received fulvestrant, 500 milligrams (mg), as an intramuscular (IM) injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter until unacceptable toxicity or PD (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab Participants received fulvestrant (fulv), 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab (atezo) 840 mg as an intravenous (IV) infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab + Ipatasertib Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and ipatasertib (ipat), 400 mg, orally (PO), once a day (QD), on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Atezolizumab + Ipatasertib Participants received atezolizumab, 840 mg as an IV infusion on Days 1 and 15 of each cycle along with ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Atezolizumab + Entinostat Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with entinostat (entino), 5 mg, PO, once a week on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab + Abemaciclib Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and abemaciclib (abem), 150 mg, PO, twice daily (BID) until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Fulvestrant Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and bevacizumab, 10 milligrams per kilogram (mg /kg), as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Exemestane Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and exemestane, 25 mg, PO, QD during each cycle until unacceptable toxicity, or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Tamoxifen Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and tamoxifen, 20 mg, PO, QD during each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 1 Death	2	1	0	0	0	3	0	0	0
Stage 1 Study Ended by Sponsor	0	0	1	0	0	1	0	0	0
Stage 1 Withdrawal by Subject	5	1	2	0	0	2	0	0	0
Stage 1 Reason Not Specified	0	0	0	0	0	1	0	0	0
Stage 1 Physician Decision	0	1	0	0	0	0	0	0	0
Stage 2 Death	0	0	0	0	0	0	0	1	0
Stage 2 Progressive Disease	0	0	0	0	0	0	2	0	0
Long-term Survival Follow-up Death	10	14	15	3	6	18	11	1	3
Long-term Survival Follow-up Study Ended by Sponsor	4	9	3	0	0	13	0	2	0
Long-term Survival Follow-up Withdrawal by Subject	1	1	1	0	1	0	0	0	0
Long-term Survival Follow-up Lost to Follow-up	0	1	1	0	2	1	0	0	0

Baseline Characteristics

Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fulvestrant Control n=25 Participants Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter until unacceptable toxicity or PD (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab n=31 Participants Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab 840 mg as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab + Ipatasertib n=27 Participants Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Atezolizumab + Ipatasertib n=6 Participants Participants received atezolizumab, 840 mg as an IV infusion on Days 1 and 15 of each cycle along with ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Atezolizumab + Entinostat n=15 Participants Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with entinostat, 5 mg, PO, once a week on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab + Abemaciclib n=40 Participants Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and abemaciclib, 150 mg, PO, BID until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Fulvestrant n=13 Participants Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and bevacizumab, 10 milligrams per kilogram (mg /kg), as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Exemestane n=4 Participants Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and exemestane, 25 mg, PO, QD during each cycle until unacceptable toxicity, or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Tamoxifen n=3 Participants Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and tamoxifen, 20 mg, PO, QD during each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.	Total n=164 Participants Total of all reporting groups
Age, Categorical Stage 1 · <=18 years	0 Participants n=25 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=31 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=27 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=6 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=15 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=40 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=144 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.
Age, Categorical Stage 1 · Between 18 and 65 years	21 Participants n=25 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	23 Participants n=31 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	22 Participants n=27 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	5 Participants n=6 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	12 Participants n=15 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	28 Participants n=40 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	111 Participants n=144 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.
Age, Categorical Stage 1 · >=65 years	4 Participants n=25 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	8 Participants n=31 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	5 Participants n=27 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	1 Participants n=6 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	3 Participants n=15 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	12 Participants n=40 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	33 Participants n=144 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.
Age, Categorical Stage 2 · <=18 years	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=13 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=4 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=3 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=20 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.
Age, Categorical Stage 2 · Between 18 and 65 years	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	10 Participants n=13 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	3 Participants n=4 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	1 Participants n=3 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	14 Participants n=20 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.
Age, Categorical Stage 2 · >=65 years	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	3 Participants n=13 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	1 Participants n=4 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	2 Participants n=3 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	6 Participants n=20 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.
Sex: Female, Male Stage 1 · Female	25 Participants n=25 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	31 Participants n=31 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	27 Participants n=27 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	6 Participants n=6 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	15 Participants n=15 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	40 Participants n=40 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	144 Participants n=144 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.
Sex: Female, Male Stage 1 · Male	0 Participants n=25 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=31 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=27 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=6 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=15 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=40 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=144 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.
Sex: Female, Male Stage 2 · Female	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	13 Participants n=13 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	4 Participants n=4 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	3 Participants n=3 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	20 Participants n=20 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.
Sex: Female, Male Stage 2 · Male	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=13 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=4 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=3 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=20 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.
Ethnicity (NIH/OMB) Stage 1 · Hispanic or Latino	1 Participants n=25 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	1 Participants n=31 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	1 Participants n=27 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=6 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=15 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=40 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	3 Participants n=144 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.
Ethnicity (NIH/OMB) Stage 1 · Not Hispanic or Latino	23 Participants n=25 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	28 Participants n=31 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	25 Participants n=27 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	6 Participants n=6 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	14 Participants n=15 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	40 Participants n=40 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	136 Participants n=144 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.
Ethnicity (NIH/OMB) Stage 1 · Unknown or Not Reported	1 Participants n=25 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	2 Participants n=31 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	1 Participants n=27 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=6 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	1 Participants n=15 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=40 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	5 Participants n=144 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.
Ethnicity (NIH/OMB) Stage 2 · Hispanic or Latino	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=13 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=4 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=3 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=20 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.
Ethnicity (NIH/OMB) Stage 2 · Not Hispanic or Latino	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	13 Participants n=13 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	3 Participants n=4 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	3 Participants n=3 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	19 Participants n=20 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.
Ethnicity (NIH/OMB) Stage 2 · Unknown or Not Reported	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=13 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	1 Participants n=4 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=3 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	1 Participants n=20 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.
Race (NIH/OMB) Stage 1 · American Indian or Alaska Native	0 Participants n=25 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=31 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=27 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=6 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=15 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=40 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=144 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.
Race (NIH/OMB) Stage 1 · Asian	8 Participants n=25 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	10 Participants n=31 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	11 Participants n=27 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=6 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	5 Participants n=15 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	15 Participants n=40 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	49 Participants n=144 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.
Race (NIH/OMB) Stage 1 · Native Hawaiian or Other Pacific Islander	0 Participants n=25 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=31 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=27 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=6 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=15 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=40 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=144 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.
Race (NIH/OMB) Stage 1 · Black or African American	1 Participants n=25 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	3 Participants n=31 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	2 Participants n=27 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=6 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=15 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	1 Participants n=40 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	7 Participants n=144 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.
Race (NIH/OMB) Stage 1 · White	12 Participants n=25 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	16 Participants n=31 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	12 Participants n=27 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	6 Participants n=6 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	9 Participants n=15 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	24 Participants n=40 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	79 Participants n=144 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.
Race (NIH/OMB) Stage 1 · More than one race	0 Participants n=25 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=31 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=27 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=6 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=15 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=40 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=144 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.
Race (NIH/OMB) Stage 1 · Unknown or Not Reported	4 Participants n=25 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	2 Participants n=31 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	2 Participants n=27 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=6 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	1 Participants n=15 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=40 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	9 Participants n=144 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.
Race (NIH/OMB) Stage 2 · American Indian or Alaska Native	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=13 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=4 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=3 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=20 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.
Race (NIH/OMB) Stage 2 · Asian	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	1 Participants n=13 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	1 Participants n=4 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=3 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	2 Participants n=20 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.
Race (NIH/OMB) Stage 2 · Native Hawaiian or Other Pacific Islander	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=13 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=4 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=3 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=20 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.
Race (NIH/OMB) Stage 2 · Black or African American	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=13 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=4 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=3 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=20 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.
Race (NIH/OMB) Stage 2 · White	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	12 Participants n=13 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=4 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	3 Participants n=3 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	15 Participants n=20 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.
Race (NIH/OMB) Stage 2 · More than one race	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=13 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=4 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=3 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=20 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.
Race (NIH/OMB) Stage 2 · Unknown or Not Reported	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=13 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	3 Participants n=4 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	0 Participants n=3 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.	3 Participants n=20 Participants • Stage 2: The number analyzed is the number of participants who experienced unacceptable toxicity, PD, or loss of clinical benefit in Stage 1 and entered Stage 2 to receive treatment.

PRIMARY outcome

Timeframe: Up to 50.4 months

Population: Efficacy-evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen.

Outcome measures

Outcome measures
Measure	Stage 1: Fulvestrant + Atezolizumab n=30 Participants Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab 840 mg as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab + Ipatasertib n=26 Participants Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Atezolizumab + Ipatasertib n=6 Participants Participants received atezolizumab, 840 mg as an IV infusion on Days 1 and 15 of each cycle along with ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Atezolizumab + Entinostat n=15 Participants Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with entinostat, 5 mg, PO, once a week on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Fulvestrant Control n=20 Participants Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter until unacceptable toxicity or PD (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab + Abemaciclib n=38 Participants Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and abemaciclib, 150 mg, PO, BID until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Fulvestrant Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and bevacizumab, 10 milligrams per kilogram (mg /kg), as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Exemestane Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and exemestane, 25 mg, PO, QD during each cycle until unacceptable toxicity, or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Tamoxifen Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and tamoxifen, 20 mg, PO, QD during each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 1: Percentage of Participants With Objective Response	10.0 percentage of participants Interval 2.11 to 26.53	26.9 percentage of participants Interval 11.57 to 47.79	16.7 percentage of participants Interval 0.42 to 64.12	6.7 percentage of participants Interval 0.17 to 31.95	10.0 percentage of participants Interval 1.23 to 31.7	26.3 percentage of participants Interval 13.4 to 43.1	—	—	—

SECONDARY outcome

Timeframe: From randomization to the first occurrence of PD or death (up to 51.9 months)

Population: Efficacy-evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen.

PFS was defined as the time from randomization to the date of the first recorded occurrence of PD or death from any cause (whichever occurred first) in Stage 1, as determined by the investigator according to RECIST v1.1. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum in the study including baseline in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥ 5 mm. Participants who did not have documented PD or death, PFS was censored at the day of the last tumor assessment. The Kaplan-Meier method was used to estimate the median for PFS.

Outcome measures

Outcome measures
Measure	Stage 1: Fulvestrant + Atezolizumab n=30 Participants Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab 840 mg as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab + Ipatasertib n=26 Participants Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Atezolizumab + Ipatasertib n=6 Participants Participants received atezolizumab, 840 mg as an IV infusion on Days 1 and 15 of each cycle along with ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Atezolizumab + Entinostat n=15 Participants Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with entinostat, 5 mg, PO, once a week on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Fulvestrant Control n=20 Participants Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter until unacceptable toxicity or PD (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab + Abemaciclib n=38 Participants Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and abemaciclib, 150 mg, PO, BID until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Fulvestrant Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and bevacizumab, 10 milligrams per kilogram (mg /kg), as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Exemestane Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and exemestane, 25 mg, PO, QD during each cycle until unacceptable toxicity, or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Tamoxifen Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and tamoxifen, 20 mg, PO, QD during each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 1: Progression-free Survival (PFS)	3.15 months Interval 1.51 to 7.79	5.86 months Interval 1.64 to 11.24	2.28 months Interval 1.41 to The upper limit of the 95% confidence interval (CI) was not estimable due to an insufficient number of participants with events.	1.82 months Interval 1.48 to 3.84	1.95 months Interval 1.45 to 4.93	6.28 months Interval 5.13 to 11.73	—	—	—

SECONDARY outcome

Timeframe: Up to 51.9 months

Population: Efficacy-evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen.

CBR was defined as the percentage of participants with stable disease (SD) ≥ 24 weeks or with confirmed CR or PR, as determined by the investigator according to RECIST v1.1. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. CR was defined as the disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) having a reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥ 5 mm. Percentages have been rounded off to the nearest whole number.

Outcome measures

Outcome measures
Measure	Stage 1: Fulvestrant + Atezolizumab n=30 Participants Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab 840 mg as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab + Ipatasertib n=26 Participants Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Atezolizumab + Ipatasertib n=6 Participants Participants received atezolizumab, 840 mg as an IV infusion on Days 1 and 15 of each cycle along with ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Atezolizumab + Entinostat n=15 Participants Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with entinostat, 5 mg, PO, once a week on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Fulvestrant Control n=20 Participants Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter until unacceptable toxicity or PD (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab + Abemaciclib n=38 Participants Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and abemaciclib, 150 mg, PO, BID until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Fulvestrant Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and bevacizumab, 10 milligrams per kilogram (mg /kg), as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Exemestane Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and exemestane, 25 mg, PO, QD during each cycle until unacceptable toxicity, or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Tamoxifen Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and tamoxifen, 20 mg, PO, QD during each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 1: Clinical Benefit Rate (CBR)	26.7 percentage of participants Interval 12.28 to 45.89	42.3 percentage of participants Interval 23.35 to 63.08	16.7 percentage of participants Interval 0.42 to 64.12	6.7 percentage of participants Interval 0.17 to 31.95	15.0 percentage of participants Interval 3.21 to 37.89	42.1 percentage of participants Interval 26.31 to 59.18	—	—	—

SECONDARY outcome

Timeframe: From randomization to death (up to 62.2 months)

Population: Efficacy-evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen.

Outcome measures

Outcome measures
Measure	Stage 1: Fulvestrant + Atezolizumab n=30 Participants Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab 840 mg as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab + Ipatasertib n=26 Participants Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Atezolizumab + Ipatasertib n=6 Participants Participants received atezolizumab, 840 mg as an IV infusion on Days 1 and 15 of each cycle along with ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Atezolizumab + Entinostat n=15 Participants Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with entinostat, 5 mg, PO, once a week on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Fulvestrant Control n=20 Participants Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter until unacceptable toxicity or PD (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab + Abemaciclib n=38 Participants Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and abemaciclib, 150 mg, PO, BID until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Fulvestrant Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and bevacizumab, 10 milligrams per kilogram (mg /kg), as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Exemestane Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and exemestane, 25 mg, PO, QD during each cycle until unacceptable toxicity, or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Tamoxifen Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and tamoxifen, 20 mg, PO, QD during each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 1: Overall Survival (OS)	26.48 months Interval 15.87 to 46.46	26.91 months Interval 20.93 to 47.41	10.91 months Interval 5.59 to Upper limit of 95% CI was not estimable due to an insufficient number of participants with events.	23.10 months Interval 15.24 to Upper limit of 95% CI was not estimable due to an insufficient number of participants with events.	26.02 months Interval 9.13 to 35.09	26.71 months Interval 22.6 to 36.17	—	—	—

SECONDARY outcome

Timeframe: At Month 18

Population: Efficacy-evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen. Overall number analyzed included all participants with data available for analysis.

OS was defined as the time from randomization to death from any cause. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. The Kaplan-Meier approach was used to estimate the percentage of participants who were event-free for OS at Month 18. Percentages have been rounded off to the nearest whole number.

Outcome measures

Outcome measures
Measure	Stage 1: Fulvestrant + Atezolizumab n=15 Participants Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab 840 mg as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab + Ipatasertib n=16 Participants Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Atezolizumab + Ipatasertib n=6 Participants Participants received atezolizumab, 840 mg as an IV infusion on Days 1 and 15 of each cycle along with ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Atezolizumab + Entinostat n=5 Participants Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with entinostat, 5 mg, PO, once a week on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Fulvestrant Control n=10 Participants Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter until unacceptable toxicity or PD (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab + Abemaciclib n=26 Participants Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and abemaciclib, 150 mg, PO, BID until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Fulvestrant Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and bevacizumab, 10 milligrams per kilogram (mg /kg), as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Exemestane Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and exemestane, 25 mg, PO, QD during each cycle until unacceptable toxicity, or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Tamoxifen Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and tamoxifen, 20 mg, PO, QD during each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 1: Percentage of Participants Event-free for OS at Month 18	63.16 percentage of participants Interval 43.97 to 82.35	81.61 percentage of participants Interval 65.22 to 98.0	NA percentage of participants The number and 95% CI was not estimable due to an insufficient number of participants with events.	75.76 percentage of participants Interval 45.17 to 100.0	63.91 percentage of participants Interval 40.55 to 87.26	74.40 percentage of participants Interval 59.97 to 88.84	—	—	—

SECONDARY outcome

Timeframe: From first occurrence of a documented OR to the first date of recorded PD or death (up to 50.4 months)

DOR was defined as the time from the first occurrence of a documented objective response (CR or PR) to the first date of recorded PD or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) having a reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum in study including baseline in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥ 5 mm. Participants who did not have documented PD or death, DOR was censored at the day of the last tumor assessment. The Kaplan-Meier method was used to estimate the median for DOR.

Outcome measures

Outcome measures
Measure	Stage 1: Fulvestrant + Atezolizumab n=3 Participants Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab 840 mg as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab + Ipatasertib n=7 Participants Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Atezolizumab + Ipatasertib n=1 Participants Participants received atezolizumab, 840 mg as an IV infusion on Days 1 and 15 of each cycle along with ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Atezolizumab + Entinostat n=1 Participants Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with entinostat, 5 mg, PO, once a week on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Fulvestrant Control n=2 Participants Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter until unacceptable toxicity or PD (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab + Abemaciclib n=10 Participants Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and abemaciclib, 150 mg, PO, BID until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Fulvestrant Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and bevacizumab, 10 milligrams per kilogram (mg /kg), as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Exemestane Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and exemestane, 25 mg, PO, QD during each cycle until unacceptable toxicity, or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Tamoxifen Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and tamoxifen, 20 mg, PO, QD during each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 1: Duration of Response (DOR)	5.88 months Interval 3.29 to The upper limit of the 95% CI was not estimable due to an insufficient number of participants with events.	11.07 months Interval 7.85 to 20.7	4.40 months The 95% CI was not estimable for a single participant.	2.46 months The 95% CI was not estimable for a single participant.	13.03 months Interval 10.15 to The upper limit of the 95% CI was not estimable due to an insufficient number of participants with events.	13.36 months Interval 8.87 to 17.02	—	—	—

SECONDARY outcome

Timeframe: From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months)

Population: SE population included all participants who received any amount of study treatment.

An AE was any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE = serious adverse events; AESIs = adverse events of special interest.

Outcome measures

Outcome measures
Measure	Stage 1: Fulvestrant + Atezolizumab n=30 Participants Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab 840 mg as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab + Ipatasertib n=26 Participants Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Atezolizumab + Ipatasertib n=6 Participants Participants received atezolizumab, 840 mg as an IV infusion on Days 1 and 15 of each cycle along with ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Atezolizumab + Entinostat n=15 Participants Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with entinostat, 5 mg, PO, once a week on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Fulvestrant Control n=20 Participants Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter until unacceptable toxicity or PD (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab + Abemaciclib n=39 Participants Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and abemaciclib, 150 mg, PO, BID until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Fulvestrant n=13 Participants Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and bevacizumab, 10 milligrams per kilogram (mg /kg), as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Exemestane n=4 Participants Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and exemestane, 25 mg, PO, QD during each cycle until unacceptable toxicity, or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Tamoxifen n=3 Participants Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and tamoxifen, 20 mg, PO, QD during each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stages 1 and 2: Number of Participants With Adverse Events (AEs)	28 Participants	26 Participants	6 Participants	15 Participants	18 Participants	39 Participants	12 Participants	3 Participants	3 Participants

SECONDARY outcome

Timeframe: Predose on Day 1 of Cycles 1 and 2; 2-4 hours postdose on Day 1 Cycle 1 (Cycle length = 21 days)

Population: Pharmacokinetic (PK) population included all participants who received at least one dose of atezolizumab and drugs given in combination with atezolizumab during Stage 1. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point.

Outcome measures

Outcome measures
Measure	Stage 1: Fulvestrant + Atezolizumab Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab 840 mg as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab + Ipatasertib Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Atezolizumab + Ipatasertib Participants received atezolizumab, 840 mg as an IV infusion on Days 1 and 15 of each cycle along with ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Atezolizumab + Entinostat Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with entinostat, 5 mg, PO, once a week on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Fulvestrant Control n=14 Participants Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter until unacceptable toxicity or PD (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab + Abemaciclib Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and abemaciclib, 150 mg, PO, BID until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Fulvestrant Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and bevacizumab, 10 milligrams per kilogram (mg /kg), as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Exemestane Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and exemestane, 25 mg, PO, QD during each cycle until unacceptable toxicity, or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Tamoxifen Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and tamoxifen, 20 mg, PO, QD during each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 1: Plasma Concentration of Entinostat Predose on Cycle 1 Day 1	—	—	—	—	NA nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA The geometric mean and geometric coefficient of variation were not estimable as sample were below the limit of quantification (BLQ).	—	—	—	—
Stage 1: Plasma Concentration of Entinostat 2-4 Hrs Postdose on Cycle 1 Day 1	—	—	—	—	22.3 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 91.0	—	—	—	—
Stage 1: Plasma Concentration of Entinostat Predose on Cycle 2 Day 1	—	—	—	—	2.12 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 60.3	—	—	—	—

SECONDARY outcome

Timeframe: Predose on Day 1 of Cycles 1, 2 and 3, and on Day 15 Cycle 1; 4-8 hours postdose on Day 1 Cycle 1 (Cycle length = 28 days)

Population: PK population included all participants who received at least one dose of atezolizumab and drugs given in combination with atezolizumab during Stage 1. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point.

Outcome measures

Outcome measures
Measure	Stage 1: Fulvestrant + Atezolizumab Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab 840 mg as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab + Ipatasertib Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Atezolizumab + Ipatasertib Participants received atezolizumab, 840 mg as an IV infusion on Days 1 and 15 of each cycle along with ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Atezolizumab + Entinostat Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with entinostat, 5 mg, PO, once a week on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Fulvestrant Control n=31 Participants Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter until unacceptable toxicity or PD (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab + Abemaciclib Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and abemaciclib, 150 mg, PO, BID until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Fulvestrant Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and bevacizumab, 10 milligrams per kilogram (mg /kg), as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Exemestane Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and exemestane, 25 mg, PO, QD during each cycle until unacceptable toxicity, or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Tamoxifen Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and tamoxifen, 20 mg, PO, QD during each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 1: Plasma Concentration of Abemaciclib Predose on Cycle 1 Day 1	—	—	—	—	0.00417 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 50.3	—	—	—	—
Stage 1: Plasma Concentration of Abemaciclib 4-8 Hour Postdose on Cycle 1 Day 1	—	—	—	—	0.0581 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 170.0	—	—	—	—
Stage 1: Plasma Concentration of Abemaciclib Predose on Cycle 1 Day 15	—	—	—	—	0.319 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 57.4	—	—	—	—
Stage 1: Plasma Concentration of Abemaciclib Predose on Cycle 2 Day 1	—	—	—	—	0.108 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 573.7	—	—	—	—
Stage 1: Plasma Concentration of Abemaciclib Predose on Cycle 3 Day 1	—	—	—	—	0.144 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 177.7	—	—	—	—

SECONDARY outcome

Timeframe: Predose and Postdose at 1 Hour, 2 Hour, 4 Hour, and 6 Hour on Day 15 Cycle 1; Post dose at 1-3 Hour on Day 15 Cycle 3 (Cycle length = 28 days)

Outcome measures

Outcome measures
Measure	Stage 1: Fulvestrant + Atezolizumab n=2 Participants Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab 840 mg as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab + Ipatasertib Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Atezolizumab + Ipatasertib Participants received atezolizumab, 840 mg as an IV infusion on Days 1 and 15 of each cycle along with ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Atezolizumab + Entinostat Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with entinostat, 5 mg, PO, once a week on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Fulvestrant Control n=11 Participants Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter until unacceptable toxicity or PD (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab + Abemaciclib Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and abemaciclib, 150 mg, PO, BID until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Fulvestrant Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and bevacizumab, 10 milligrams per kilogram (mg /kg), as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Exemestane Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and exemestane, 25 mg, PO, QD during each cycle until unacceptable toxicity, or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Tamoxifen Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and tamoxifen, 20 mg, PO, QD during each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 1: Plasma Concentration of Ipatasertib Predose on Cycle 1 Day 15	0.0105 µg/mL Geometric Coefficient of Variation 10113.9	—	—	—	0.0353 µg/mL Geometric Coefficient of Variation 248.9	—	—	—	—
Stage 1: Plasma Concentration of Ipatasertib 1 Hour Postdose on Cycle 1 Day 15	0.203 µg/mL Geometric Coefficient of Variation 38.5	—	—	—	0.154 µg/mL Geometric Coefficient of Variation 185.0	—	—	—	—
Stage 1: Plasma Concentration of Ipatasertib 2 Hour Postdose on Cycle 1 Day 15	0.398 µg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.	—	—	—	0.447 µg/mL Geometric Coefficient of Variation 53.7	—	—	—	—
Stage 1: Plasma Concentration of Ipatasertib 4 Hour Postdose on Cycle 1 Day 15	0.303 µg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.	—	—	—	0.273 µg/mL Geometric Coefficient of Variation 45.9	—	—	—	—
Stage 1: Plasma Concentration of Ipatasertib 6 Hour Postdose on Cycle 1 Day 15	0.227 µg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.	—	—	—	0.203 µg/mL Geometric Coefficient of Variation 45.4	—	—	—	—
Stage 1: Plasma Concentration of Ipatasertib 1-3 Hour Postdose on Cycle 3 Day 15	0.0664 µg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.	—	—	—	0.576 µg/mL Geometric Coefficient of Variation 25.9	—	—	—	—

SECONDARY outcome

Timeframe: Predose on Day 1 of Cycle 2 and Cycle 3 (Cycle length = 28 days)

Outcome measures

Outcome measures
Measure	Stage 1: Fulvestrant + Atezolizumab n=9 Participants Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab 840 mg as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab + Ipatasertib n=7 Participants Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Atezolizumab + Ipatasertib Participants received atezolizumab, 840 mg as an IV infusion on Days 1 and 15 of each cycle along with ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Atezolizumab + Entinostat Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with entinostat, 5 mg, PO, once a week on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Fulvestrant Control n=1 Participants Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter until unacceptable toxicity or PD (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab + Abemaciclib Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and abemaciclib, 150 mg, PO, BID until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Fulvestrant Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and bevacizumab, 10 milligrams per kilogram (mg /kg), as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Exemestane Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and exemestane, 25 mg, PO, QD during each cycle until unacceptable toxicity, or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Tamoxifen Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and tamoxifen, 20 mg, PO, QD during each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 1: Plasma Concentration of Fulvestrant Predose on Cycle 2 Day 1	0.0136 µg/mL Geometric Coefficient of Variation 60.2	0.0161 µg/mL Geometric Coefficient of Variation 74.3	—	—	0.0127 µg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.	—	—	—	—
Stage 1: Plasma Concentration of Fulvestrant Predose on Cycle 3 Day 1	0.0107 µg/mL Geometric Coefficient of Variation 40.3	0.0121 µg/mL Geometric Coefficient of Variation 38.0	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose on Day 1 of Cycles 2 and 3 (Cycle length = 21 days)

Nominal time restarted to 0 at Stage 2. PK data for Stage was analyzed and reported for the subgroups \[crossover arms (Stage 1 to Stage 2)\] only.

Outcome measures

Outcome measures
Measure	Stage 1: Fulvestrant + Atezolizumab n=1 Participants Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab 840 mg as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab + Ipatasertib n=3 Participants Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Atezolizumab + Ipatasertib Participants received atezolizumab, 840 mg as an IV infusion on Days 1 and 15 of each cycle along with ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Atezolizumab + Entinostat Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with entinostat, 5 mg, PO, once a week on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Fulvestrant Control n=3 Participants Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter until unacceptable toxicity or PD (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab + Abemaciclib Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and abemaciclib, 150 mg, PO, BID until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Fulvestrant Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and bevacizumab, 10 milligrams per kilogram (mg /kg), as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Exemestane Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and exemestane, 25 mg, PO, QD during each cycle until unacceptable toxicity, or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Tamoxifen Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and tamoxifen, 20 mg, PO, QD during each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 2: Plasma Concentration of Fulvestrant Predose on Day 1 Cycle 2 (Stage 2)	0.00938 µg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.	0.0142 µg/mL Geometric Coefficient of Variation 41.2	—	—	0.0207 µg/mL Geometric Coefficient of Variation 14.1	—	—	—	—
Stage 2: Plasma Concentration of Fulvestrant Predose on Day 1 Cycle 3 (Stage 2)	0.0175 µg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.	0.0132 µg/mL Geometric Coefficient of Variation 10.3	—	—	0.0121 µg/mL Geometric Coefficient of Variation 39.3	—	—	—	—

SECONDARY outcome

Timeframe: Predose on Day 1 of Cycles 1, 2, 3, 4, 8 and 12; 30 minutes (mins) postdose on Day 1 Cycle 1; postdose on Day 120 and Treatment Discontinuation Visit (Cycle length = 21 days)

Nominal time restarted to 0 at Stage 2; RO5541267 = atezolizumab. PK data for Stage was analyzed and reported for the subgroups \[crossover arms (Stage 1 to Stage 2)\] only.

Outcome measures

Outcome measures
Measure	Stage 1: Fulvestrant + Atezolizumab n=5 Participants Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab 840 mg as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab + Ipatasertib n=1 Participants Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Atezolizumab + Ipatasertib n=2 Participants Participants received atezolizumab, 840 mg as an IV infusion on Days 1 and 15 of each cycle along with ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Atezolizumab + Entinostat n=1 Participants Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with entinostat, 5 mg, PO, once a week on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Fulvestrant Control n=1 Participants Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter until unacceptable toxicity or PD (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab + Abemaciclib n=1 Participants Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and abemaciclib, 150 mg, PO, BID until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Fulvestrant n=1 Participants Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and bevacizumab, 10 milligrams per kilogram (mg /kg), as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Exemestane n=1 Participants Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and exemestane, 25 mg, PO, QD during each cycle until unacceptable toxicity, or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Tamoxifen n=3 Participants Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and tamoxifen, 20 mg, PO, QD during each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 2: Serum Concentration of Atezolizumab Predose on Day 1 Cycle 4 (Stage 2)	302 µg/mL Geometric Coefficient of Variation 20.8	—	115 µg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.	341 µg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.	—	310 µg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.	—	238 µg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.	309 µg/mL Geometric Coefficient of Variation 35.2
Stage 2: Serum Concentration of Atezolizumab Predose on Day 1 Cycle 1 (Stage 2)	128 µg/mL Geometric Coefficient of Variation 49.2	443 µg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.	160 µg/mL Geometric Coefficient of Variation 209.6	277 µg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.	217 µg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.	167 µg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.	NA µg/mL Geometric Coefficient of Variation NA The geometric mean and geometric coefficient of variation were not estimable as samples were BLQ.	NA µg/mL Geometric Coefficient of Variation NA The geometric mean and geometric coefficient of variation were not estimable as samples were BLQ.	16.3 µg/mL Geometric Coefficient of Variation 63062.7
Stage 2: Serum Concentration of Atezolizumab 30 mins postdose on Day 1 Cycle 1 (Stage 2)	388 µg/mL Geometric Coefficient of Variation 22.3	907 µg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.	725 µg/mL Geometric Coefficient of Variation 52.9	1030 µg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.	617 µg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.	679 µg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.	498 µg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.	—	491 µg/mL Geometric Coefficient of Variation 16.3
Stage 2: Serum Concentration of Atezolizumab Predose on Day 1 Cycle 2 (Stage 2)	251 µg/mL Geometric Coefficient of Variation 35.8	434 µg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.	211 µg/mL Geometric Coefficient of Variation 143.9	373 µg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.	202 µg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.	253 µg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.	141 µg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.	136 µg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.	227 µg/mL Geometric Coefficient of Variation 65.2
Stage 2: Serum Concentration of Atezolizumab Predose on Day 1 Cycle 3 (Stage 2)	318 µg/mL Geometric Coefficient of Variation 8.8	—	208 µg/mL Geometric Coefficient of Variation 93.2	333 µg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.	—	284 µg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.	—	220 µg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.	274 µg/mL Geometric Coefficient of Variation 47.4
Stage 2: Serum Concentration of Atezolizumab Predose on Day 1 Cycle 8 (Stage 2)	—	—	—	—	—	—	—	—	131 µg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.
Stage 2: Serum Concentration of Atezolizumab Predose on Day 1 Cycle 12 (Stage 2)	—	—	—	—	—	—	—	—	182 µg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.
Stage 2: Serum Concentration of Atezolizumab Postdose on Day 120 (Stage 2)	27.4 µg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.	—	30.0 µg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.	—	—	—	22.6 µg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.	—	7.38 µg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.
Stage 2: Serum Concentration of Atezolizumab Treatment Discontinuation Visit (Stage 2)	250 µg/mL Geometric Coefficient of Variation 18.9	450 µg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.	130 µg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.	—	—	—	—	201 µg/mL Geometric Coefficient of Variation NA Since only 1 participant was evaluable, the geometric coefficient of variation could not be estimated.	169 µg/mL Geometric Coefficient of Variation 145.8

SECONDARY outcome

Timeframe: Post-baseline (up to approximately 134 days)

Population: Pharmacodynamic (PD) population included all participants in the atezolizumab plus entinostat arm with at least one ADA assessment.

Participants who received atezolizumab were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following atezolizumab exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the titer of the baseline sample (treatment-enhanced ADA response). Participants were considered to be treatment-emergent ADA-negative if they were ADA-negative or were missing data at baseline and all post-baseline samples were negative, or if they were ADA-positive at baseline but did not have any post-baseline samples with a titer that was at least 0.60 t.u. greater than the titer of the baseline sample (treatment unaffected). Participants with a positive post-baseline sample has been reported here.

Outcome measures

Outcome measures
Measure	Stage 1: Fulvestrant + Atezolizumab n=2 Participants Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab 840 mg as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab + Ipatasertib n=3 Participants Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Atezolizumab + Ipatasertib Participants received atezolizumab, 840 mg as an IV infusion on Days 1 and 15 of each cycle along with ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Atezolizumab + Entinostat Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with entinostat, 5 mg, PO, once a week on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Fulvestrant Control n=10 Participants Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter until unacceptable toxicity or PD (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab + Abemaciclib Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and abemaciclib, 150 mg, PO, BID until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Fulvestrant Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and bevacizumab, 10 milligrams per kilogram (mg /kg), as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Exemestane Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and exemestane, 25 mg, PO, QD during each cycle until unacceptable toxicity, or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Tamoxifen Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and tamoxifen, 20 mg, PO, QD during each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Stage 2: Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab	0 Participants	0 Participants	—	—	0 Participants	—	—	—	—

Adverse Events

Fulvestrant Control

Serious events: 2 serious events

Other events: 18 other events

Deaths: 12 deaths

Stage 1: Fulvestrant + Atezolizumab

Serious events: 3 serious events

Other events: 28 other events

Deaths: 16 deaths

Stage 1: Fulvestrant + Atezolizumab + Ipatasertib

Serious events: 12 serious events

Other events: 25 other events

Deaths: 15 deaths

Stage 1: Atezolizumab + Ipatasertib

Serious events: 3 serious events

Other events: 6 other events

Deaths: 3 deaths

Stage 1: Atezolizumab + Entinostat

Serious events: 4 serious events

Other events: 15 other events

Deaths: 6 deaths

Stage 1: Fulvestrant + Atezolizumab + Abemaciclib

Serious events: 14 serious events

Other events: 38 other events

Deaths: 23 deaths

Stage 2: Atezolizumab + Bevacizumab + Fulvestrant

Serious events: 1 serious events

Other events: 12 other events

Deaths: 11 deaths

Stage 2: Atezolizumab + Bevacizumab + Exemestane

Serious events: 1 serious events

Other events: 3 other events

Deaths: 2 deaths

Stage 2: Atezolizumab + Bevacizumab + Tamoxifen

Serious events: 0 serious events

Other events: 3 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Fulvestrant Control n=20 participants at risk Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter until unacceptable toxicity or PD (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab n=30 participants at risk Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab 840 mg as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab + Ipatasertib n=26 participants at risk Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Atezolizumab + Ipatasertib n=6 participants at risk Participants received atezolizumab, 840 mg as an IV infusion on Days 1 and 15 of each cycle along with ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Atezolizumab + Entinostat n=15 participants at risk Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with entinostat, 5 mg, PO, once a week on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab + Abemaciclib n=39 participants at risk Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and abemaciclib, 150 mg, PO, BID until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Fulvestrant n=13 participants at risk Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and bevacizumab, 10 milligrams per kilogram (mg /kg), as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Exemestane n=4 participants at risk Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and exemestane, 25 mg, PO, QD during each cycle until unacceptable toxicity, or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Tamoxifen n=3 participants at risk Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and tamoxifen, 20 mg, PO, QD during each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Blood and lymphatic system disorders Anaemia	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.8% 1/26 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	5.1% 2/39 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Blood and lymphatic system disorders Leukocytosis	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Cardiac disorders Angina pectoris	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Cardiac disorders Myocarditis	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Cardiac disorders Pericardial effusion	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.3% 1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	16.7% 1/6 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Endocrine disorders Adrenal insufficiency	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	25.0% 1/4 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Endocrine disorders Immune-mediated adrenal insufficiency	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.3% 1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Gastrointestinal disorders Abdominal distension	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Gastrointestinal disorders Abdominal pain	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.8% 1/26 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	16.7% 1/6 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Gastrointestinal disorders Colitis	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.8% 1/26 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Gastrointestinal disorders Diarrhoea	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.8% 1/26 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Gastrointestinal disorders Dysphagia	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	16.7% 1/6 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Gastrointestinal disorders Haematochezia	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
General disorders Pyrexia	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	16.7% 1/6 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	20.0% 3/15 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Hepatobiliary disorders Hepatotoxicity	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	16.7% 1/6 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Infections and infestations Appendicitis	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Infections and infestations Clostridium difficile infection	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Infections and infestations Epstein-Barr virus infection	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.8% 1/26 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Infections and infestations Sepsis	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	5.1% 2/39 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Injury, poisoning and procedural complications Fall	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Injury, poisoning and procedural complications Injury	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Injury, poisoning and procedural complications Transfusion reaction	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Investigations Alanine aminotransferase increased	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Investigations Aspartate aminotransferase increased	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	5.1% 2/39 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Investigations Blood alkaline phosphatase increased	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Investigations Hepatic enzyme increased	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myxofibrosarcoma	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Nervous system disorders Amnesia	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.8% 1/26 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Nervous system disorders Headache	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Nervous system disorders Neuropathy peripheral	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Nervous system disorders Presyncope	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.3% 1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Psychiatric disorders Mental status changes	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.8% 1/26 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Renal and urinary disorders Acute kidney injury	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	5.1% 2/39 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Renal and urinary disorders Haematuria	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.8% 1/26 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.8% 1/26 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.8% 1/26 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	16.7% 1/6 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.8% 1/26 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	16.7% 1/6 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	11.5% 3/26 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Skin and subcutaneous tissue disorders Rash	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	11.5% 3/26 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	33.3% 2/6 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.

Other adverse events

Other adverse events
Measure	Fulvestrant Control n=20 participants at risk Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter until unacceptable toxicity or PD (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab n=30 participants at risk Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab 840 mg as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab + Ipatasertib n=26 participants at risk Participants received fulvestrant, 500 mg, as an IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Atezolizumab + Ipatasertib n=6 participants at risk Participants received atezolizumab, 840 mg as an IV infusion on Days 1 and 15 of each cycle along with ipatasertib, 400 mg, PO, QD, on Days 1 to 21 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Atezolizumab + Entinostat n=15 participants at risk Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with entinostat, 5 mg, PO, once a week on Days 1, 8, and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 1: Fulvestrant + Atezolizumab + Abemaciclib n=39 participants at risk Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and abemaciclib, 150 mg, PO, BID until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). After Stage 1, participants who did not enter Stage 2 entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Fulvestrant n=13 participants at risk Participants received fulvestrant, 500 mg, as IM injection on Days 1 and 15 of Cycle 1 and on Day 1 of each cycle thereafter along with atezolizumab, 840 mg, as an IV infusion on Days 1 and 15 of each cycle and bevacizumab, 10 milligrams per kilogram (mg /kg), as an IV infusion on Days 1 and 15 of each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 28 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Exemestane n=4 participants at risk Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and exemestane, 25 mg, PO, QD during each cycle until unacceptable toxicity, or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.	Stage 2: Atezolizumab + Bevacizumab + Tamoxifen n=3 participants at risk Participants received atezolizumab, 1200 mg, as an IV infusion on Day 1 of each cycle along with bevacizumab, 15 mg/kg, as an IV infusion on Day 1 of each cycle and tamoxifen, 20 mg, PO, QD during each cycle until unacceptable toxicity or loss of clinical benefit (1 cycle = 21 days). Participants who completed Stage 2 treatment entered the long-term survival follow-up.
Blood and lymphatic system disorders Anaemia	5.0% 1/20 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	13.3% 4/30 • Number of events 8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 2/26 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	33.3% 13/39 • Number of events 17 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 7 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Blood and lymphatic system disorders Neutropenia	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	13.3% 2/15 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	25.6% 10/39 • Number of events 26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	16.7% 1/6 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	13.3% 2/15 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	5.1% 2/39 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Cardiac disorders Cardiac failure	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Cardiac disorders Coronary artery disease	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.3% 1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Cardiac disorders Myocardial infarction	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Cardiac disorders Palpitations	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	5.1% 2/39 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Ear and labyrinth disorders Vertigo	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.3% 1/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.8% 1/26 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Endocrine disorders Hyperthyroidism	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	16.7% 1/6 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	5.1% 2/39 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Endocrine disorders Hypothyroidism	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.8% 1/26 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	23.1% 9/39 • Number of events 9 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	25.0% 1/4 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Eye disorders Cataract	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	5.1% 2/39 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Eye disorders Dry eye	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	16.7% 1/6 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	5.1% 2/39 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Eye disorders Eyelid skin dryness	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Eye disorders Vision blurred	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	10.0% 3/30 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Gastrointestinal disorders Abdominal pain	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	13.3% 4/30 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 2/26 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	20.0% 3/15 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	23.1% 9/39 • Number of events 9 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Gastrointestinal disorders Abdominal pain upper	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	10.0% 3/30 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 2/26 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	5.1% 2/39 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Gastrointestinal disorders Ascites	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Gastrointestinal disorders Cheilitis	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Gastrointestinal disorders Colitis	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Gastrointestinal disorders Constipation	15.0% 3/20 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	23.3% 7/30 • Number of events 8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	46.2% 12/26 • Number of events 14 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	50.0% 3/6 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	10.3% 4/39 • Number of events 6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Gastrointestinal disorders Diarrhoea	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	20.0% 6/30 • Number of events 9 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	53.8% 14/26 • Number of events 33 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	66.7% 4/6 • Number of events 6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	13.3% 2/15 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	84.6% 33/39 • Number of events 55 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Gastrointestinal disorders Dry mouth	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.3% 1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	13.3% 2/15 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Gastrointestinal disorders Dyspepsia	10.0% 2/20 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.3% 1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	11.5% 3/26 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	12.8% 5/39 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Gastrointestinal disorders Dysphagia	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.8% 1/26 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Gastrointestinal disorders Eructation	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Gastrointestinal disorders Gastrooesophageal reflux disease	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.3% 1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 2/26 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Gastrointestinal disorders Haemorrhoids	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Gastrointestinal disorders Nausea	20.0% 4/20 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	26.7% 8/30 • Number of events 14 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	53.8% 14/26 • Number of events 23 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	66.7% 4/6 • Number of events 6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	33.3% 5/15 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	43.6% 17/39 • Number of events 23 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	38.5% 5/13 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Gastrointestinal disorders Oral discomfort	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Gastrointestinal disorders Oral dysaesthesia	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Gastrointestinal disorders Stomatitis	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 2/30 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	12.8% 5/39 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Gastrointestinal disorders Toothache	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	5.1% 2/39 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Gastrointestinal disorders Vomiting	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	10.0% 3/30 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	26.9% 7/26 • Number of events 12 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	50.0% 3/6 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	26.7% 4/15 • Number of events 6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	30.8% 12/39 • Number of events 20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
General disorders Asthenia	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 2/26 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	16.7% 1/6 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	17.9% 7/39 • Number of events 8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
General disorders Catheter site pain	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
General disorders Chest discomfort	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.8% 1/26 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
General disorders Chest pain	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
General disorders Chills	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.8% 1/26 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	20.0% 3/15 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
General disorders Discomfort	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
General disorders Fatigue	20.0% 4/20 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	36.7% 11/30 • Number of events 13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	34.6% 9/26 • Number of events 10 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	50.0% 3/6 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	26.7% 4/15 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	43.6% 17/39 • Number of events 26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	53.8% 7/13 • Number of events 8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	25.0% 1/4 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
General disorders Injection site pain	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.8% 1/26 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
General disorders Mucosal inflammation	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.8% 1/26 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	5.1% 2/39 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
General disorders Non-cardiac chest pain	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.8% 1/26 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
General disorders Oedema peripheral	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	33.3% 2/6 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	20.0% 3/15 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	5.1% 2/39 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
General disorders Pain	10.0% 2/20 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	10.0% 3/30 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
General disorders Pyrexia	10.0% 2/20 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	10.0% 3/30 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	23.1% 6/26 • Number of events 7 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	16.7% 1/6 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	20.0% 3/15 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	12.8% 5/39 • Number of events 23 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
General disorders Swelling	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	16.7% 1/6 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Hepatobiliary disorders Hepatitis	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.8% 1/26 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	25.0% 1/4 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Immune system disorders Hypersensitivity	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Infections and infestations COVID-19	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.3% 1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.8% 1/26 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	10.3% 4/39 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Infections and infestations Candida infection	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.3% 1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	33.3% 2/6 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Infections and infestations Cystitis	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	10.3% 4/39 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Infections and infestations Eye infection	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Infections and infestations Gingivitis	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Infections and infestations Oral herpes	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.8% 1/26 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	5.1% 2/39 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Infections and infestations Periodontitis	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	5.1% 2/39 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Infections and infestations Pneumonia	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 3/39 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Infections and infestations Postoperative abscess	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Infections and infestations Rhinitis	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Infections and infestations Skin infection	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Infections and infestations Tooth infection	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Infections and infestations Upper respiratory tract infection	10.0% 2/20 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.3% 1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.8% 1/26 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	10.3% 4/39 • Number of events 6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Infections and infestations Urinary tract infection	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 2/26 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	16.7% 1/6 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	5.1% 2/39 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	15.4% 2/13 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Infections and infestations Viral infection	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 2/26 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Injury, poisoning and procedural complications Contusion	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.3% 1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.8% 1/26 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 3/39 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	25.0% 1/4 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Injury, poisoning and procedural complications Mouth injury	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Injury, poisoning and procedural complications Procedural pain	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Injury, poisoning and procedural complications Wound complication	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Investigations Alanine aminotransferase increased	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	15.4% 4/26 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	13.3% 2/15 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	15.4% 6/39 • Number of events 13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Investigations Amylase increased	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	16.7% 1/6 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Investigations Aspartate aminotransferase increased	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	10.0% 3/30 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	15.4% 4/26 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	13.3% 2/15 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	20.5% 8/39 • Number of events 15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	15.4% 2/13 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Investigations Blood alkaline phosphatase increased	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	11.5% 3/26 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	5.1% 2/39 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Investigations Blood creatine phosphokinase increased	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Investigations Blood creatinine increased	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	15.4% 6/39 • Number of events 11 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Investigations Blood lactate dehydrogenase increased	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Investigations Ejection fraction decreased	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Investigations Electrocardiogram QT prolonged	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Investigations Gamma-glutamyltransferase increased	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.8% 1/26 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Investigations Hepatic enzyme increased	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 3/39 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Investigations Liver function test increased	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	16.7% 1/6 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	25.0% 1/4 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Investigations Neutrophil count decreased	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	10.0% 3/30 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	23.1% 9/39 • Number of events 36 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Investigations Platelet count decreased	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.3% 1/30 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	12.8% 5/39 • Number of events 11 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Investigations SARS-CoV-2 test positive	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Investigations Wall motion score index abnormal	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Investigations Weight decreased	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	16.7% 1/6 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	15.4% 6/39 • Number of events 6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Investigations Weight increased	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Investigations White blood cell count decreased	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.3% 1/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	13.3% 2/15 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	5.1% 2/39 • Number of events 8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Metabolism and nutrition disorders Decreased appetite	10.0% 2/20 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	13.3% 4/30 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	19.2% 5/26 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	66.7% 4/6 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	26.7% 4/15 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	33.3% 13/39 • Number of events 14 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 2/26 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	16.7% 1/6 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 3/39 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Metabolism and nutrition disorders Hypercalcaemia	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	5.1% 2/39 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	25.0% 1/4 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.3% 1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	11.5% 3/26 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	5.1% 2/39 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.3% 1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Metabolism and nutrition disorders Hypocalcaemia	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Metabolism and nutrition disorders Hypokalaemia	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 2/26 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	16.7% 1/6 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	10.3% 4/39 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.3% 1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	5.1% 2/39 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Metabolism and nutrition disorders Hypophosphataemia	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.3% 1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.8% 1/26 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	5.1% 2/39 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	25.0% 1/4 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	25.0% 5/20 • Number of events 6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	33.3% 10/30 • Number of events 13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	11.5% 3/26 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	13.3% 2/15 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	10.3% 4/39 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	23.1% 3/13 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	33.3% 1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 2/26 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Musculoskeletal and connective tissue disorders Back pain	15.0% 3/20 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	13.3% 4/30 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 2/26 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	16.7% 1/6 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	25.6% 10/39 • Number of events 12 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	33.3% 1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Musculoskeletal and connective tissue disorders Bone pain	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	5.1% 2/39 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.3% 1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.3% 1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.8% 1/26 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.8% 1/26 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 3/39 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	33.3% 1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.3% 1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.8% 1/26 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	26.7% 4/15 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	12.8% 5/39 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	15.4% 2/13 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Musculoskeletal and connective tissue disorders Neck pain	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.8% 1/26 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	5.1% 2/39 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	10.0% 2/20 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	13.3% 4/30 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	11.5% 3/26 • Number of events 6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	12.8% 5/39 • Number of events 7 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	33.3% 1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	33.3% 1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Nervous system disorders Balance disorder	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Nervous system disorders Dizziness	15.0% 3/20 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	10.0% 3/30 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 2/26 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	50.0% 3/6 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	20.0% 3/15 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 3/39 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	25.0% 1/4 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Nervous system disorders Dysgeusia	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.3% 1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.8% 1/26 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	16.7% 1/6 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	5.1% 2/39 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Nervous system disorders Headache	10.0% 2/20 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	16.7% 5/30 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	19.2% 5/26 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	20.0% 3/15 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	12.8% 5/39 • Number of events 6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	23.1% 3/13 • Number of events 6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	25.0% 1/4 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	33.3% 1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Nervous system disorders Hypoaesthesia	5.0% 1/20 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.3% 1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 2/26 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	16.7% 1/6 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Nervous system disorders Hypokinesia	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Nervous system disorders Lethargy	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	16.7% 1/6 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Nervous system disorders Paraesthesia	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.8% 1/26 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.3% 1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.8% 1/26 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Nervous system disorders Restless legs syndrome	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Nervous system disorders Syncope	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 2/26 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Nervous system disorders Tremor	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	16.7% 1/6 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	5.1% 2/39 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Psychiatric disorders Anxiety	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Psychiatric disorders Confusional state	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Psychiatric disorders Insomnia	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	5.1% 2/39 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Psychiatric disorders Mood altered	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Psychiatric disorders Nightmare	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Psychiatric disorders Procedural anxiety	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Renal and urinary disorders Dysuria	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.3% 1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	16.7% 1/6 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	5.1% 2/39 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Renal and urinary disorders Hypertonic bladder	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Renal and urinary disorders Proteinuria	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	30.8% 4/13 • Number of events 5 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	25.0% 1/4 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Renal and urinary disorders Stress urinary incontinence	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Renal and urinary disorders Urinary incontinence	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders Autoimmune lung disease	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders Cough	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	23.3% 7/30 • Number of events 9 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	26.9% 7/26 • Number of events 8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	50.0% 3/6 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	26.7% 4/15 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 3/39 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	25.0% 1/4 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	10.0% 3/30 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	11.5% 3/26 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	16.7% 1/6 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	13.3% 2/15 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	5.1% 2/39 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	25.0% 1/4 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.3% 1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.0% 1/20 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.3% 1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	10.0% 3/30 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	5.1% 2/39 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 2/26 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.3% 1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.8% 1/26 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	5.1% 2/39 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Skin and subcutaneous tissue disorders Acne	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	5.1% 2/39 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.8% 1/26 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	16.7% 1/6 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	5.1% 2/39 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.3% 1/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.8% 1/26 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	10.0% 3/30 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	16.7% 1/6 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.3% 1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.8% 1/26 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 2/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Skin and subcutaneous tissue disorders Panniculitis	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Skin and subcutaneous tissue disorders Pigmentation disorder	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	5.1% 2/39 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Skin and subcutaneous tissue disorders Pruritus	10.0% 2/20 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	13.3% 4/30 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	11.5% 3/26 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	16.7% 1/6 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	23.1% 9/39 • Number of events 12 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Skin and subcutaneous tissue disorders Rash	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	10.0% 3/30 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	53.8% 14/26 • Number of events 18 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	25.6% 10/39 • Number of events 13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	16.7% 1/6 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	10.0% 3/30 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	11.5% 3/26 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	10.3% 4/39 • Number of events 4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.3% 1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.8% 1/26 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/39 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 1/13 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Vascular disorders Hot flush	10.0% 2/20 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.3% 1/30 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/26 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	5.1% 2/39 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	33.3% 1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Vascular disorders Hypertension	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.3% 1/30 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	7.7% 2/26 • Number of events 3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/6 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/15 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	46.2% 6/13 • Number of events 8 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	25.0% 1/4 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	33.3% 1/3 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.
Vascular disorders Hypotension	0.00% 0/20 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/30 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	3.8% 1/26 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	33.3% 2/6 • Number of events 2 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	6.7% 1/15 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	2.6% 1/39 • Number of events 1 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/13 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/4 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.	0.00% 0/3 • From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 52 months; Stage 2: up to 21.7 months) All-cause mortality: Stage 1: up to approximately 62.2 months; Stage 2: From study initiation (from Stage 1) up to approximately 63.7 months) All-Cause Mortality: Randomized population included all participants enrolled, regardless if treatment was received. SAEs and Other AEs: SE population included all participants who received any amount of study treatment.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER