Trial Outcomes & Findings for Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naïve CLL (NCT NCT02475681)

Last Updated: 2025-08-27

Results Overview

To evaluate the efficacy of obinutuzumab in combination with chlorambucil (Arm A) compared with acalabrutinib in combination with obinutuzumab (Arm B) based on IRC assessment of progression-free survival (PFS) per International Workshop on Chronic Lymphocytic Leukemia criteria (IWCLL; Hallek et al. 2008) with incorporation of the clarification for treatment-related lymphocytosis (Cheson et al. 2012), hereafter referred to as IWCLL 2008 criteria, in subjects with previously untreated CLL. PFS, defined as the time from date of randomization to the date of first IRC-assessed disease progression or death due to any cause, whichever comes first.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

535 participants

Primary outcome timeframe

IRC assessments were done from randomization date until disease progression or death or IRC discontinuation date on 08Feb2019 (as the IA based on this data cutoff date showed the study crossing superiority boundary) whichever comes first up to 40 months.

Results posted on

2025-08-27

Participant Flow

A randomized, multicenter, open-label, 3 arm phase 3 study of Obinutuzumab in combination with Chlorambucil (Chlb+Obin), Acalabrutinib in combination with Obinutuzumab (Acala+Obin), and Acalabrutinib monotherapy (Acala) in subjects with previously untreated chronic lymphocytic leukemia. A total of 535 subjects recruited from 142 sites in 18 countries were randomized (1:1:1) as follows: 179/179 /177 subjects in Acla+Obin arm / Acala arm / Chlb+Obin arm respectively.

Participant milestones

Participant milestones
Measure	Arm A: Obinutuzumab in Combination With Chlorambucil Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles, starting from cycle1 to cycle 6. Chlorambucil will be orally administered on Days 1 and 15 of Cycles 1 through 6. At investigator discretion, subjects randomized to this treatment arm, who had IRC-confirmed disease progression, were eligible to receive crossover treatment with single-agent acalabrutinib at 100 mg BID until disease progression or unacceptable toxicity.	Arm B: Acalabrutinib in Combination With Obinutuzumab Acalabrutinib (ACP-196) will be orally administered starting on Cycle 1 Day 1. Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles, starting in Cycle 2 Day 1. Daily administration of Acalabrutinib (ACP-196) will continue until disease progression or unacceptable toxicity.	Arm C: Acalabrutinib Monotherapy Acalabrutinib (ACP-196) will be orally administered on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Acalabrutinib
Overall Study STARTED	177	179	179
Overall Study Crossed Over From Arm A to Arm C	45	0	0
Overall Study COMPLETED	145	0	0
Overall Study NOT COMPLETED	32	179	179

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A: Obinutuzumab in Combination With Chlorambucil Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles, starting from cycle1 to cycle 6. Chlorambucil will be orally administered on Days 1 and 15 of Cycles 1 through 6. At investigator discretion, subjects randomized to this treatment arm, who had IRC-confirmed disease progression, were eligible to receive crossover treatment with single-agent acalabrutinib at 100 mg BID until disease progression or unacceptable toxicity.	Arm B: Acalabrutinib in Combination With Obinutuzumab Acalabrutinib (ACP-196) will be orally administered starting on Cycle 1 Day 1. Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles, starting in Cycle 2 Day 1. Daily administration of Acalabrutinib (ACP-196) will continue until disease progression or unacceptable toxicity.	Arm C: Acalabrutinib Monotherapy Acalabrutinib (ACP-196) will be orally administered on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Acalabrutinib
Overall Study Death	16	6	9
Overall Study Physician Decision	0	3	1
Overall Study Withdrawal by Subject	12	6	9
Overall Study Lost to Follow-up	2	1	3
Overall Study Ongoing in Study	0	163	157
Overall Study Reasons other than above listed	2	0	0

Baseline Characteristics

Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naïve CLL

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Obinutuzumab in Combination With Chlorambucil n=177 Participants Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles starting at Cycle 1 Day 1. Chlorambucil will be orally administered on Days 1 and 15 of Cycles 1 through 6. Obinutuzumab Chlorambucil	Acalabrutinib in Combination With Obinutuzumab n=179 Participants Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles starting at Cycle 2 Day 1. Acalabrutinib (ACP-196) will be orally administered starting on Cycle 1 Day 1. Daily administration of Acalabrutinib (ACP-196) will continue until disease progression or unacceptable toxicity. Acalabrutinib Obinutuzumab	Acalabrutinib Monotherapy n=179 Participants Acalabrutinib will be orally administered on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Acalabrutinib	Total n=535 Participants Total of all reporting groups
Region of Enrollment Italy	11 Participants n=93 Participants	9 Participants n=4 Participants	5 Participants n=27 Participants	25 Participants n=483 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=93 Participants	35 Participants n=4 Participants	28 Participants n=27 Participants	87 Participants n=483 Participants
Age, Categorical >=65 years	153 Participants n=93 Participants	144 Participants n=4 Participants	151 Participants n=27 Participants	448 Participants n=483 Participants
Sex: Female, Male Female	71 Participants n=93 Participants	68 Participants n=4 Participants	68 Participants n=27 Participants	207 Participants n=483 Participants
Sex: Female, Male Male	106 Participants n=93 Participants	111 Participants n=4 Participants	111 Participants n=27 Participants	328 Participants n=483 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=93 Participants	2 Participants n=4 Participants	11 Participants n=27 Participants	24 Participants n=483 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	156 Participants n=93 Participants	169 Participants n=4 Participants	156 Participants n=27 Participants	481 Participants n=483 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	10 Participants n=93 Participants	8 Participants n=4 Participants	12 Participants n=27 Participants	30 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	3 Participants n=4 Participants	0 Participants n=27 Participants	3 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Race (NIH/OMB) Black or African American	4 Participants n=93 Participants	5 Participants n=4 Participants	4 Participants n=27 Participants	13 Participants n=483 Participants
Race (NIH/OMB) White	165 Participants n=93 Participants	164 Participants n=4 Participants	170 Participants n=27 Participants	499 Participants n=483 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=93 Participants	7 Participants n=4 Participants	5 Participants n=27 Participants	18 Participants n=483 Participants
Region of Enrollment Belgium	5 Participants n=93 Participants	5 Participants n=4 Participants	3 Participants n=27 Participants	13 Participants n=483 Participants
Region of Enrollment France	3 Participants n=93 Participants	3 Participants n=4 Participants	1 Participants n=27 Participants	7 Participants n=483 Participants
Region of Enrollment Germany	3 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants	7 Participants n=483 Participants
Region of Enrollment Spain	7 Participants n=93 Participants	3 Participants n=4 Participants	3 Participants n=27 Participants	13 Participants n=483 Participants
Region of Enrollment Sweden	1 Participants n=93 Participants	3 Participants n=4 Participants	3 Participants n=27 Participants	7 Participants n=483 Participants
Region of Enrollment United Kingdom	12 Participants n=93 Participants	16 Participants n=4 Participants	17 Participants n=27 Participants	45 Participants n=483 Participants
Region of Enrollment Brazil	4 Participants n=93 Participants	5 Participants n=4 Participants	5 Participants n=27 Participants	14 Participants n=483 Participants
Region of Enrollment Chile	2 Participants n=93 Participants	0 Participants n=4 Participants	3 Participants n=27 Participants	5 Participants n=483 Participants
Region of Enrollment Colombia	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Region of Enrollment Canada	7 Participants n=93 Participants	8 Participants n=4 Participants	7 Participants n=27 Participants	22 Participants n=483 Participants
Region of Enrollment United States	54 Participants n=93 Participants	56 Participants n=4 Participants	63 Participants n=27 Participants	173 Participants n=483 Participants
Region of Enrollment Hungary	17 Participants n=93 Participants	26 Participants n=4 Participants	15 Participants n=27 Participants	58 Participants n=483 Participants
Region of Enrollment Lithuania	9 Participants n=93 Participants	2 Participants n=4 Participants	6 Participants n=27 Participants	17 Participants n=483 Participants
Region of Enrollment Poland	14 Participants n=93 Participants	20 Participants n=4 Participants	25 Participants n=27 Participants	59 Participants n=483 Participants
Region of Enrollment Australia	9 Participants n=93 Participants	9 Participants n=4 Participants	8 Participants n=27 Participants	26 Participants n=483 Participants
Region of Enrollment New Zealand	8 Participants n=93 Participants	4 Participants n=4 Participants	5 Participants n=27 Participants	17 Participants n=483 Participants
Region of Enrollment Israel	10 Participants n=93 Participants	9 Participants n=4 Participants	7 Participants n=27 Participants	26 Participants n=483 Participants
IXRS Randomization Stratification Factor: Presence of 17p Deletion Yes	17 Participants n=93 Participants	21 Participants n=4 Participants	19 Participants n=27 Participants	57 Participants n=483 Participants
IXRS Randomization Stratification Factor: Presence of 17p Deletion No	160 Participants n=93 Participants	158 Participants n=4 Participants	160 Participants n=27 Participants	478 Participants n=483 Participants
IXRS Randomization Stratification Factor: ECOG Performance Status 0-1 (0=Fully Active; 1 =Restricted in Physically Strenuous Activity)	168 Participants n=93 Participants	169 Participants n=4 Participants	167 Participants n=27 Participants	504 Participants n=483 Participants
IXRS Randomization Stratification Factor: ECOG Performance Status 2 (2=Ambulatory and capable of all selfcare but unable to carry out any work activities)	9 Participants n=93 Participants	10 Participants n=4 Participants	12 Participants n=27 Participants	31 Participants n=483 Participants
IXRS Randomization Stratification Factor: Geographic Region North America and West Europe	103 Participants n=93 Participants	104 Participants n=4 Participants	105 Participants n=27 Participants	312 Participants n=483 Participants
IXRS Randomization Stratification Factor: Geographic Region Other	74 Participants n=93 Participants	75 Participants n=4 Participants	74 Participants n=27 Participants	223 Participants n=483 Participants

PRIMARY outcome

Timeframe: IRC assessments were done from randomization date until disease progression or death or IRC discontinuation date on 08Feb2019 (as the IA based on this data cutoff date showed the study crossing superiority boundary) whichever comes first up to 40 months.

Population: Intent to Treat (ITT)

Outcome measures

Outcome measures
Measure	Arm A: Obinutuzumab in Combination With Chlorambucil n=177 Participants Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles, starting from cycle1 to cycle 6. Chlorambucil will be orally administered on Days 1 and 15 of Cycles 1 through 6. At investigator discretion, subjects randomized to this treatment arm, who had IRC-confirmed disease progression, were eligible to receive crossover treatment with single-agent acalabrutinib at 100 mg BID until disease progression or unacceptable toxicity.	Arm B: Acalabrutinib in Combination With Obinutuzumab n=179 Participants Acalabrutinib (ACP-196) will be orally administered starting on Cycle 1 Day 1. Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles, starting in Cycle 2 Day 1. Daily administration of Acalabrutinib (ACP-196) will continue until disease progression or unacceptable toxicity.	Arm C: Acalabrutinib Monotherapy Acalabrutinib (ACP-196) will be orally administered on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Acalabrutinib
Progression-free Survival by IRC (Independent Review Committee) Assessment in Arm A Compared to Arm B	22.6 Months Interval 20.2 to 27.8	NA Months Median and 95% CIs for Arm B = NA (not reached) since insufficient numbers of subjects with events (Range = 0.0+ to 39.4+ months). "+" indicates a value from a censored subject.	—

SECONDARY outcome

Population: Intent to Treat (ITT)

To evaluate the efficacy of obinutuzumab in combination with chlorambucil (Arm A) compared with acalabrutinib monotherapy (Arm C) based on IRC assessment of progression-free survival (PFS) per International Workshop on Chronic Lymphocytic Leukemia criteria (IWCLL; Hallek et al. 2008) with incorporation of the clarification for treatment-related lymphocytosis (Cheson et al. 2012), hereafter referred to as IWCLL 2008 criteria, in subjects with previously untreated CLL. PFS, defined as the time from date of randomization to the date of first IRC-assessed disease progression or death due to any cause, whichever comes first.

Outcome measures

Outcome measures
Measure	Arm A: Obinutuzumab in Combination With Chlorambucil n=177 Participants Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles, starting from cycle1 to cycle 6. Chlorambucil will be orally administered on Days 1 and 15 of Cycles 1 through 6. At investigator discretion, subjects randomized to this treatment arm, who had IRC-confirmed disease progression, were eligible to receive crossover treatment with single-agent acalabrutinib at 100 mg BID until disease progression or unacceptable toxicity.	Arm B: Acalabrutinib in Combination With Obinutuzumab n=179 Participants Acalabrutinib (ACP-196) will be orally administered starting on Cycle 1 Day 1. Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles, starting in Cycle 2 Day 1. Daily administration of Acalabrutinib (ACP-196) will continue until disease progression or unacceptable toxicity.	Arm C: Acalabrutinib Monotherapy Acalabrutinib (ACP-196) will be orally administered on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Acalabrutinib
Progression-free Survival by IRC Assessment Arm A Versus Arm C	22.6 Months Interval 20.2 to 27.6	NA Months Interval 34.2 to The median PFS for Arm C was not reached (Range = 0.0+ to 39.5+ months). "+" indicates a value from a censored subject.	—

SECONDARY outcome

Population: Intent to Treat

ORR was defined as the proportion of subjects who achieved a best response of CR, CRi, nPR, or PR at or before initiation of subsequent anticancer therapy. ORR including PRL was defined as the proportion of subjects who achieved a best response of CR, CRi, nPR, PR or PRL at or before initiation of subsequent anticancer therapy

Outcome measures

Outcome measures
Measure	Arm A: Obinutuzumab in Combination With Chlorambucil n=177 Participants Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles, starting from cycle1 to cycle 6. Chlorambucil will be orally administered on Days 1 and 15 of Cycles 1 through 6. At investigator discretion, subjects randomized to this treatment arm, who had IRC-confirmed disease progression, were eligible to receive crossover treatment with single-agent acalabrutinib at 100 mg BID until disease progression or unacceptable toxicity.	Arm B: Acalabrutinib in Combination With Obinutuzumab n=179 Participants Acalabrutinib (ACP-196) will be orally administered starting on Cycle 1 Day 1. Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles, starting in Cycle 2 Day 1. Daily administration of Acalabrutinib (ACP-196) will continue until disease progression or unacceptable toxicity.	Arm C: Acalabrutinib Monotherapy n=179 Participants Acalabrutinib (ACP-196) will be orally administered on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Acalabrutinib
IRC-assessed Objective Response Rate (ORR) in Arm A Versus Arm B and Arm A Versus Arm C	78.5 percentage of participants Interval 71.9 to 83.9	93.9 percentage of participants Interval 89.3 to 96.5	85.5 percentage of participants Interval 79.6 to 89.9

SECONDARY outcome

Timeframe: From randomization date to start of non-protocol specified subsequent anticancer therapy for CLL or death due to any cause, whichever came first assessed up to 40 months of follow-up.

Population: Intent to Treat (ITT)

TTNT was defined as the time from randomization to start date of non-protocol specified subsequent anticancer therapy for CLL or death due to any cause, whichever came first. TTNT was analyzed in the same fashion as that for the primary efficacy analysis

Outcome measures

Outcome measures
Measure	Arm A: Obinutuzumab in Combination With Chlorambucil n=177 Participants Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles, starting from cycle1 to cycle 6. Chlorambucil will be orally administered on Days 1 and 15 of Cycles 1 through 6. At investigator discretion, subjects randomized to this treatment arm, who had IRC-confirmed disease progression, were eligible to receive crossover treatment with single-agent acalabrutinib at 100 mg BID until disease progression or unacceptable toxicity.	Arm B: Acalabrutinib in Combination With Obinutuzumab n=179 Participants Acalabrutinib (ACP-196) will be orally administered starting on Cycle 1 Day 1. Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles, starting in Cycle 2 Day 1. Daily administration of Acalabrutinib (ACP-196) will continue until disease progression or unacceptable toxicity.	Arm C: Acalabrutinib Monotherapy n=179 Participants Acalabrutinib (ACP-196) will be orally administered on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Acalabrutinib
Time to Next Treatment (TTNT) in Arm A Versus Arm B and Arm A Versus Arm C	NA Months Interval 28.9 to The median TTNT was not reached for obinutuzumab+chlorambucil (range: 0.0+ to 39.6+ months). "+" indicates a value from a censored subject.	NA Months The median TTNT was not reached for acalabrutinib+obinutuzumab (range: 1.3-40.3+ months). "+" indicates a value from a censored subject.	NA Months The median TTNT was not reached for acalabrutinib monotherapy (range: 0.1+ to 40.1+ months). "+" indicates a value from a censored subject.

SECONDARY outcome

Timeframe: From randomization date until death, withdrawal by subject, lost to follow-up, or by analysis data cut off date on 08Feb2019 whichever comes first up to 40 months of follow-up.

Population: Intent to Treat (ITT)

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

Outcome measures

Outcome measures
Measure	Arm A: Obinutuzumab in Combination With Chlorambucil n=177 Participants Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles, starting from cycle1 to cycle 6. Chlorambucil will be orally administered on Days 1 and 15 of Cycles 1 through 6. At investigator discretion, subjects randomized to this treatment arm, who had IRC-confirmed disease progression, were eligible to receive crossover treatment with single-agent acalabrutinib at 100 mg BID until disease progression or unacceptable toxicity.	Arm B: Acalabrutinib in Combination With Obinutuzumab n=179 Participants Acalabrutinib (ACP-196) will be orally administered starting on Cycle 1 Day 1. Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles, starting in Cycle 2 Day 1. Daily administration of Acalabrutinib (ACP-196) will continue until disease progression or unacceptable toxicity.	Arm C: Acalabrutinib Monotherapy n=179 Participants Acalabrutinib (ACP-196) will be orally administered on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Acalabrutinib
Overall Survival (OS) in Arm A Versus Arm B and Arm A Versus Arm C	NA Months The median and corresponding 95% CI for the OS in Arm A was not reached due to insufficient subjects with events (Range of OS =1.7 to 40.4+ months). "+" indicates a value from a censored subject.	NA Months The median and corresponding 95% CI for the OS in Arm B was not reached due to insufficient subjects with events (Range of OS =0.1+ to 40.8+ months). "+" indicates a value from a censored subject.	NA Months The median and corresponding 95% CI for the OS in Arm C was not reached due to insufficient subjects with events. (Range of OS = 0.0+ to 40.7+ months) "+" indicates a value from a censored subject.

Adverse Events

Arm A: Obinutuzumab in Combination With Chlorambucil

Serious events: 37 serious events

Other events: 167 other events

Deaths: 17 deaths

Arm B: Acalabrutinib in Combination With Obinutuzumab

Serious events: 69 serious events

Other events: 171 other events

Deaths: 9 deaths

Arm C: Acalabrutinib Monotherapy

Serious events: 57 serious events

Other events: 170 other events

Deaths: 11 deaths

Arm A Cross-over: Obinutuzumab+Chlorambucil Crossover to Acalabrutinib Monotherapy

Serious events: 6 serious events

Other events: 37 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

Acerta Clinical Trials

Phone: 18882929613

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Institution/Investigator will not publish or publicly present any study results without prior approval or prior to 12 months following completion of the study.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Arm A: Obinutuzumab in Combination With Chlorambucil n=169 participants at risk Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles, starting from cycle1 to cycle 6. Chlorambucil will be orally administered on Days 1 and 15 of Cycles 1 through 6. At investigator discretion, subjects randomized to this treatment arm, who had IRC-confirmed disease progression, were eligible to receive crossover treatment with single-agent acalabrutinib at 100 mg BID until disease progression or unacceptable toxicity.	Arm B: Acalabrutinib in Combination With Obinutuzumab n=178 participants at risk Acalabrutinib (ACP-196) will be orally administered starting on Cycle 1 Day 1. Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles, starting in Cycle 2 Day 1. Daily administration of Acalabrutinib (ACP-196) will continue until disease progression or unacceptable toxicity.	Arm C: Acalabrutinib Monotherapy n=179 participants at risk Acalabrutinib will be orally administered on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Acalabrutinib	Arm A Cross-over: Obinutuzumab+Chlorambucil Crossover to Acalabrutinib Monotherapy n=45 participants at risk Obinutuzumab + Chlorambucil Crossover to Acalabrutinib 100 mg twice daily monotherapy
Nervous system disorders Ischaemic stroke	0.00% 0/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.56% 1/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Nervous system disorders Presyncope	0.59% 1/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.56% 1/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.56% 1/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Nervous system disorders Syncope	0.00% 0/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.56% 1/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Nervous system disorders Transient ischaemic attack	0.00% 0/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.56% 1/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Nervous system disorders Brain injury	0.00% 0/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.56% 1/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Nervous system disorders Cerebral ischaemia	0.00% 0/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.56% 1/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Nervous system disorders Ischaemic cerebral infarction	0.00% 0/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.56% 1/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Nervous system disorders Parkinson's disease	0.00% 0/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.56% 1/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Psychiatric disorders Delirium	0.00% 0/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.56% 1/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Renal and urinary disorders Acute kidney injury	0.59% 1/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	1.1% 2/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Renal and urinary disorders Calculus urinary	0.00% 0/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.56% 1/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Renal and urinary disorders Renal colic	0.00% 0/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.56% 1/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.56% 1/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Renal and urinary disorders Hydronephrosis	0.00% 0/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.56% 1/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Renal and urinary disorders Ureterolithiasis	0.00% 0/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.56% 1/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.56% 1/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	1.1% 2/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.59% 1/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.59% 1/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.56% 1/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Respiratory, thoracic and mediastinal disorders Tonsillar cyst	0.00% 0/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.56% 1/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Respiratory, thoracic and mediastinal disorders Hypoxia	1.2% 2/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.59% 1/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.56% 1/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	1.7% 3/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Blood and lymphatic system disorders Anaemia	0.00% 0/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	1.7% 3/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	2.2% 4/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Blood and lymphatic system disorders Febrile neutropenia	4.1% 7/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	1.7% 3/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	1.1% 2/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	2.2% 1/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Blood and lymphatic system disorders Autoimmune haemolytic anaemia	0.00% 0/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	1.1% 2/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Blood and lymphatic system disorders Haemolysis	0.59% 1/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.56% 1/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Blood and lymphatic system disorders Iron deficiency anaemia	0.59% 1/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Blood and lymphatic system disorders Neutropenia	0.59% 1/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.56% 1/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Cardiac disorders Acute coronary syndrome	0.00% 0/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.56% 1/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Cardiac disorders Acute myocardial infarction	0.59% 1/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.56% 1/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	1.7% 3/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	2.2% 1/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Cardiac disorders Angina unstable	0.00% 0/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.56% 1/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Cardiac disorders Atrial fibrillation	0.00% 0/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.56% 1/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Cardiac disorders Atrial flutter	0.00% 0/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.56% 1/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Cardiac disorders Atrioventricular block complete	0.00% 0/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.56% 1/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Cardiac disorders Hypertensive heart disease	0.00% 0/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.56% 1/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Cardiac disorders Myocardial infarction	0.00% 0/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.56% 1/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.56% 1/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Cardiac disorders Myocardial ischaemia	0.00% 0/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.56% 1/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Cardiac disorders Pericardial effusion	0.00% 0/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.56% 1/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).

Other adverse events
Measure	Arm A: Obinutuzumab in Combination With Chlorambucil n=169 participants at risk Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles, starting from cycle1 to cycle 6. Chlorambucil will be orally administered on Days 1 and 15 of Cycles 1 through 6. At investigator discretion, subjects randomized to this treatment arm, who had IRC-confirmed disease progression, were eligible to receive crossover treatment with single-agent acalabrutinib at 100 mg BID until disease progression or unacceptable toxicity.	Arm B: Acalabrutinib in Combination With Obinutuzumab n=178 participants at risk Acalabrutinib (ACP-196) will be orally administered starting on Cycle 1 Day 1. Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles, starting in Cycle 2 Day 1. Daily administration of Acalabrutinib (ACP-196) will continue until disease progression or unacceptable toxicity.	Arm C: Acalabrutinib Monotherapy n=179 participants at risk Acalabrutinib will be orally administered on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Acalabrutinib	Arm A Cross-over: Obinutuzumab+Chlorambucil Crossover to Acalabrutinib Monotherapy n=45 participants at risk Obinutuzumab + Chlorambucil Crossover to Acalabrutinib 100 mg twice daily monotherapy
Blood and lymphatic system disorders Neutropenia	45.0% 76/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	31.5% 56/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	10.6% 19/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	2.2% 1/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Blood and lymphatic system disorders Thrombocytopenia	14.2% 24/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	12.9% 23/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	7.3% 13/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	6.7% 3/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Blood and lymphatic system disorders Anaemia	11.8% 20/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	11.8% 21/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	14.0% 25/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Gastrointestinal disorders Diarrhoea	21.3% 36/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	38.8% 69/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	34.6% 62/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	17.8% 8/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Gastrointestinal disorders Nausea	31.4% 53/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	20.2% 36/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	22.3% 40/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	20.0% 9/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Gastrointestinal disorders Constipation	10.1% 17/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	14.0% 25/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	11.2% 20/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	11.1% 5/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Gastrointestinal disorders Vomiting	11.2% 19/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	13.5% 24/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	12.3% 22/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	4.4% 2/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Gastrointestinal disorders Abdominal pain	7.1% 12/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	6.2% 11/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	5.0% 9/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	6.7% 3/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Gastrointestinal disorders Abdominal pain upper	2.4% 4/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	6.2% 11/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	4.5% 8/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	2.2% 1/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Gastrointestinal disorders Dyspepsia	4.7% 8/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	5.1% 9/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	7.8% 14/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	4.4% 2/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Gastrointestinal disorders Gastrooesophageal reflux disease	3.6% 6/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	1.7% 3/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	6.1% 11/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	4.4% 2/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
General disorders Fatigue	17.2% 29/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	28.1% 50/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	18.4% 33/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	13.3% 6/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
General disorders Pyrexia	20.7% 35/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	12.9% 23/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	6.7% 12/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	11.1% 5/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
General disorders Oedema peripheral	7.1% 12/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	12.4% 22/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	8.9% 16/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	6.7% 3/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
General disorders Chills	8.3% 14/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	11.2% 20/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	4.5% 8/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
General disorders Asthenia	5.9% 10/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	9.6% 17/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	5.0% 9/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	2.2% 1/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
General disorders Peripheral swelling	2.4% 4/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	5.1% 9/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	5.0% 9/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	4.4% 2/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
General disorders Influenza like illness	2.4% 4/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	4.5% 8/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	6.7% 12/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	2.2% 1/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Infections and infestations Upper respiratory tract infection	8.3% 14/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	21.3% 38/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	18.4% 33/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	13.3% 6/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Infections and infestations Urinary tract infection	4.7% 8/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	12.4% 22/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	12.3% 22/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	6.7% 3/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Infections and infestations Nasopharyngitis	4.1% 7/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	11.2% 20/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	9.5% 17/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	8.9% 4/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Infections and infestations Sinusitis	3.6% 6/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	9.0% 16/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	6.7% 12/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Infections and infestations Bronchitis	3.0% 5/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	8.4% 15/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	7.8% 14/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	4.4% 2/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Infections and infestations Pneumonia	3.0% 5/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	10.7% 19/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	7.3% 13/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	2.2% 1/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Infections and infestations Herpes zoster	2.4% 4/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	6.2% 11/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	2.8% 5/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	2.2% 1/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Injury, poisoning and procedural complications Contusion	4.1% 7/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	23.6% 42/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	15.1% 27/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	11.1% 5/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Injury, poisoning and procedural complications Infusion related reaction	39.6% 67/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	13.5% 24/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	2.2% 1/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Injury, poisoning and procedural complications Fall	2.4% 4/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	7.9% 14/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	6.1% 11/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Metabolism and nutrition disorders Decreased appetite	7.7% 13/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	10.1% 18/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	5.6% 10/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	4.4% 2/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Metabolism and nutrition disorders Hypokalaemia	1.2% 2/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	6.7% 12/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	1.1% 2/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Metabolism and nutrition disorders Hyperglycaemia	3.0% 5/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	5.1% 9/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	1.1% 2/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Metabolism and nutrition disorders Hyperuricaemia	5.3% 9/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	4.5% 8/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	2.2% 4/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	2.2% 1/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Musculoskeletal and connective tissue disorders Arthralgia	4.7% 8/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	21.9% 39/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	15.6% 28/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	6.7% 3/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Musculoskeletal and connective tissue disorders Back pain	8.3% 14/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	14.0% 25/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	14.0% 25/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	8.9% 4/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Musculoskeletal and connective tissue disorders Pain in extremity	4.1% 7/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	12.4% 22/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	6.1% 11/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	6.7% 3/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Musculoskeletal and connective tissue disorders Myalgia	2.4% 4/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	7.9% 14/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	8.4% 15/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	0.00% 0/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	1.8% 3/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	7.3% 13/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	5.6% 10/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	4.4% 2/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Musculoskeletal and connective tissue disorders Neck pain	1.2% 2/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	5.1% 9/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	5.6% 10/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	2.2% 1/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Nervous system disorders Headache	11.8% 20/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	39.9% 71/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	36.9% 66/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	22.2% 10/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
Nervous system disorders Dizziness	5.9% 10/169 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	18.0% 32/178 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	11.7% 21/179 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).	8.9% 4/45 • All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years. Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).