Trial Outcomes & Findings for A Study of Tislelizumab in Combination With Chemotherapy Versus Chemotherapy in Advanced Lung Cancer (NCT NCT03594747)

NCT ID: NCT03594747

Last Updated: 2024-10-26

Results Overview

PFS is defined as the time from randomization until first documentation of disease progression as assessed by the IRC per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death from any cause, whichever occurs first

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 360 participants
• Primary outcome timeframe: Through primary analysis data cut-off date of 06DEC2019 (up to approximately 1 year and 4 months)
• Results posted on: 2024-10-26

Participant Flow

This study was conducted at multiple study centers in China. Data are presented as of the study completion data cut-off date of 28APR2023.

Participant milestones

Measure	Tislelizumab + Paclitaxel + Carboplatin Tislelizumab 200 milligrams (mg) plus paclitaxel 175 mg/m\^2 and carboplatin area under the plasma or serum concentration-time curve (AUC) 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)	Tislelizumab + Nab-paclitaxel + Carboplatin Tislelizumab 200 mg on Day 1 plus Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; Nab-paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)	Paclitaxel + Carboplatin Paclitaxel 175 mg/m\^2 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks for 4 to 6 cycles (each cycle is 21 days)
Overall Study STARTED	120	119	121
Overall Study Randomized But Not Treated	0	1	4
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	120	119	121

Reasons for withdrawal

Measure	Tislelizumab + Paclitaxel + Carboplatin Tislelizumab 200 milligrams (mg) plus paclitaxel 175 mg/m\^2 and carboplatin area under the plasma or serum concentration-time curve (AUC) 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)	Tislelizumab + Nab-paclitaxel + Carboplatin Tislelizumab 200 mg on Day 1 plus Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; Nab-paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)	Paclitaxel + Carboplatin Paclitaxel 175 mg/m\^2 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks for 4 to 6 cycles (each cycle is 21 days)
Overall Study Death	78	86	87
Overall Study Withdrawal by Subject	5	2	11
Overall Study Lost to Follow-up	4	1	1
Overall Study Physician Decision	0	1	0
Overall Study Sponsor decision	23	17	16
Overall Study Did not meet inclusion criteria	0	0	1
Overall Study Transfer to long term extension study	10	12	5

Baseline Characteristics

A Study of Tislelizumab in Combination With Chemotherapy Versus Chemotherapy in Advanced Lung Cancer

Baseline characteristics by cohort

Measure	Tislelizumab + Paclitaxel + Carboplatin n=120 Participants Tislelizumab 200 milligrams (mg) plus paclitaxel 175 mg/m\^2 and carboplatin area under the plasma or serum concentration-time curve (AUC) 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)	Tislelizumab + Nab-paclitaxel + Carboplatin n=119 Participants Tislelizumab 200 mg on Day 1 plus Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; Nab-paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)	Paclitaxel + Carboplatin n=121 Participants Paclitaxel 175 mg/m\^2 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks for 4 to 6 cycles (each cycle is 21 days)	Total n=360 Participants Total of all reporting groups
Age, Continuous	60.0 Years n=5 Participants	64.0 Years n=7 Participants	63.0 Years n=5 Participants	62.5 Years n=4 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants	30 Participants n=4 Participants
Sex: Female, Male Male	107 Participants n=5 Participants	112 Participants n=7 Participants	111 Participants n=5 Participants	330 Participants n=4 Participants
Race/Ethnicity, Customized Asian	120 Participants n=5 Participants	119 Participants n=7 Participants	121 Participants n=5 Participants	360 Participants n=4 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	120 Participants n=5 Participants	119 Participants n=7 Participants	121 Participants n=5 Participants	360 Participants n=4 Participants

PRIMARY outcome

Timeframe: Through primary analysis data cut-off date of 06DEC2019 (up to approximately 1 year and 4 months)

Population: ITT analysis set included all participants who were randomized

PFS is defined as the time from randomization until first documentation of disease progression as assessed by the IRC per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death from any cause, whichever occurs first

Outcome measures

Measure	Tislelizumab + Paclitaxel + Carboplatin n=120 Participants Tislelizumab 200 milligrams (mg) plus paclitaxel 175 mg/m\^2 and carboplatin area under the plasma or serum concentration-time curve (AUC) 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)	Tislelizumab + Nab-paclitaxel + Carboplatin n=119 Participants Tislelizumab 200 mg on Day 1 plus Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; Nab-paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)	Paclitaxel + Carboplatin n=121 Participants Paclitaxel 175 mg/m\^2 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks for 4 to 6 cycles (each cycle is 21 days)
Progression Free Survival (PFS) by Independent Review Committee (IRC) Assessment as of Data Cut-off Date of 06DEC2019	7.6 Months Interval 5.95 to 9.79	7.6 Months Interval 5.75 to 11.01	5.5 Months Interval 4.21 to 5.65

PRIMARY outcome

Timeframe: Through primary analysis data cut-off date of 30SEP2020 (up to approximately 2 years and 2 months)

Population: ITT analysis set included all participants who were randomized

PFS is defined as the time from randomization until first documentation of disease progression as assessed by the IRC per RECIST v1.1 or death from any cause, whichever occurs first

Outcome measures

Measure	Tislelizumab + Paclitaxel + Carboplatin n=120 Participants Tislelizumab 200 milligrams (mg) plus paclitaxel 175 mg/m\^2 and carboplatin area under the plasma or serum concentration-time curve (AUC) 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)	Tislelizumab + Nab-paclitaxel + Carboplatin n=119 Participants Tislelizumab 200 mg on Day 1 plus Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; Nab-paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)	Paclitaxel + Carboplatin n=121 Participants Paclitaxel 175 mg/m\^2 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks for 4 to 6 cycles (each cycle is 21 days)
PFS by IRC Assessment as of Data Cut-off Date of 30SEP2020	7.7 Months Interval 6.74 to 10.41	9.6 Months Interval 7.39 to 10.78	5.5 Months Interval 4.21 to 5.59

SECONDARY outcome

Timeframe: Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months)

Population: ITT analysis set included all participants who were randomized

OS is defined as the time from randomization until the date of death due to any cause

Outcome measures

Measure	Tislelizumab + Paclitaxel + Carboplatin n=120 Participants Tislelizumab 200 milligrams (mg) plus paclitaxel 175 mg/m\^2 and carboplatin area under the plasma or serum concentration-time curve (AUC) 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)	Tislelizumab + Nab-paclitaxel + Carboplatin n=119 Participants Tislelizumab 200 mg on Day 1 plus Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; Nab-paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)	Paclitaxel + Carboplatin n=121 Participants Paclitaxel 175 mg/m\^2 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks for 4 to 6 cycles (each cycle is 21 days)
Overall Survival (OS)	26.1 Months Interval 18.99 to 33.81	23.3 Months Interval 18.76 to 26.38	19.4 Months Interval 15.97 to 23.43

SECONDARY outcome

Timeframe: Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months)

Population: ITT analysis set included all participants who were randomized

ORR is defined as the percentage of participants with complete response (CR) and partial response (PR), as assessed by the IRC using RECIST v1.1.

Outcome measures

Measure	Tislelizumab + Paclitaxel + Carboplatin n=120 Participants Tislelizumab 200 milligrams (mg) plus paclitaxel 175 mg/m\^2 and carboplatin area under the plasma or serum concentration-time curve (AUC) 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)	Tislelizumab + Nab-paclitaxel + Carboplatin n=119 Participants Tislelizumab 200 mg on Day 1 plus Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; Nab-paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)	Paclitaxel + Carboplatin n=121 Participants Paclitaxel 175 mg/m\^2 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks for 4 to 6 cycles (each cycle is 21 days)
Objective Response Rate (ORR) by IRC Assessment	74.2 Percentage of participants Interval 65.4 to 81.7	73.9 Percentage of participants Interval 65.1 to 81.6	47.9 Percentage of participants Interval 38.8 to 57.2

SECONDARY outcome

Timeframe: Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months)

Population: ITT analysis set included all participants who were randomized

ORR is defined as the percentage of participants with complete response (CR) and partial response (PR), as assessed by the investigator using RECIST v1.1.

Outcome measures

Measure	Tislelizumab + Paclitaxel + Carboplatin n=120 Participants Tislelizumab 200 milligrams (mg) plus paclitaxel 175 mg/m\^2 and carboplatin area under the plasma or serum concentration-time curve (AUC) 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)	Tislelizumab + Nab-paclitaxel + Carboplatin n=119 Participants Tislelizumab 200 mg on Day 1 plus Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; Nab-paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)	Paclitaxel + Carboplatin n=121 Participants Paclitaxel 175 mg/m\^2 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks for 4 to 6 cycles (each cycle is 21 days)
ORR by Investigator Assessment	70.0 Percentage of participants Interval 61.0 to 78.0	78.2 Percentage of participants Interval 69.6 to 85.2	49.6 Percentage of participants Interval 40.4 to 58.8

SECONDARY outcome

Timeframe: Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months)

Population: ITT analysis set included all participants who were randomized

DOR is defined as the time from the first occurrence of a documented objective response to the time of documented disease progression assessed by the IRC using RECIST v1.1, or death from any cause, whichever comes first, in all randomized participants with documented objective responses. Data are based on number of responders.

Outcome measures

Measure	Tislelizumab + Paclitaxel + Carboplatin n=89 Participants Tislelizumab 200 milligrams (mg) plus paclitaxel 175 mg/m\^2 and carboplatin area under the plasma or serum concentration-time curve (AUC) 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)	Tislelizumab + Nab-paclitaxel + Carboplatin n=88 Participants Tislelizumab 200 mg on Day 1 plus Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; Nab-paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)	Paclitaxel + Carboplatin n=58 Participants Paclitaxel 175 mg/m\^2 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks for 4 to 6 cycles (each cycle is 21 days)
Duration of Response (DOR) by IRC Assessment	8.4 Months Interval 5.03 to 18.69	8.6 Months Interval 7.13 to 12.48	4.3 Months Interval 2.86 to 5.42

SECONDARY outcome

Timeframe: Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months)

Population: ITT analysis set included all participants who were randomized

DOR is defined as the time from the first occurrence of a documented objective response to the time of documented disease progression assessed by the investigator using RECIST v1.1, or death from any cause, whichever comes first, in all randomized participants with documented objective responses. Data are based on number of responders.

Outcome measures

Measure	Tislelizumab + Paclitaxel + Carboplatin n=84 Participants Tislelizumab 200 milligrams (mg) plus paclitaxel 175 mg/m\^2 and carboplatin area under the plasma or serum concentration-time curve (AUC) 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)	Tislelizumab + Nab-paclitaxel + Carboplatin n=93 Participants Tislelizumab 200 mg on Day 1 plus Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; Nab-paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)	Paclitaxel + Carboplatin n=60 Participants Paclitaxel 175 mg/m\^2 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks for 4 to 6 cycles (each cycle is 21 days)
DOR by Investigator Assessment	10.6 Months Interval 7.03 to 16.23	8.8 Months Interval 8.05 to 11.93	4.8 Months Interval 2.86 to 6.11

SECONDARY outcome

Timeframe: Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months)

Population: ITT analysis set included all participants who were randomized

PFS is defined as the time from randomization until first documentation of disease progression as assessed by the investigator per RECIST v1.1 or death from any cause, whichever occurs first

Outcome measures

Measure	Tislelizumab + Paclitaxel + Carboplatin n=120 Participants Tislelizumab 200 milligrams (mg) plus paclitaxel 175 mg/m\^2 and carboplatin area under the plasma or serum concentration-time curve (AUC) 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)	Tislelizumab + Nab-paclitaxel + Carboplatin n=119 Participants Tislelizumab 200 mg on Day 1 plus Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; Nab-paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)	Paclitaxel + Carboplatin n=121 Participants Paclitaxel 175 mg/m\^2 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks for 4 to 6 cycles (each cycle is 21 days)
PFS by Investigator Assessment	9.6 Months Interval 7.62 to 11.76	9.8 Months Interval 8.57 to 11.86	5.5 Months Interval 4.17 to 5.65

SECONDARY outcome

Timeframe: Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months)

Population: ITT analysis set included all participants who were randomized; participants evaluable for PD-L1 expression were included

PFS is defined as the time from randomization until first documentation of disease progression as assessed by the IRC per RECIST v1.1 or death from any cause, whichever occurs first, based on PD-L1 expression in tumor cells

Outcome measures

Measure	Tislelizumab + Paclitaxel + Carboplatin n=119 Participants Tislelizumab 200 milligrams (mg) plus paclitaxel 175 mg/m\^2 and carboplatin area under the plasma or serum concentration-time curve (AUC) 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)	Tislelizumab + Nab-paclitaxel + Carboplatin n=118 Participants Tislelizumab 200 mg on Day 1 plus Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; Nab-paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)	Paclitaxel + Carboplatin n=117 Participants Paclitaxel 175 mg/m\^2 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks for 4 to 6 cycles (each cycle is 21 days)
PFS by IRC Based on Programmed Death Ligand 1 (PD-L1) Expression PD-L Expression (<1%)	7.6 Months Interval 5.5 to 14.5	7.6 Months Interval 5.4 to 9.9	5.5 Months Interval 4.2 to 7.0
PFS by IRC Based on Programmed Death Ligand 1 (PD-L1) Expression PD-L Expression (1% to 49%)	9.9 Months Interval 5.5 to 22.7	9.8 Months Interval 7.6 to 12.0	5.0 Months Interval 2.8 to 6.5
PFS by IRC Based on Programmed Death Ligand 1 (PD-L1) Expression PD-L Expression (≥ 50%)	7.7 Months Interval 5.9 to 9.8	9.7 Months Interval 5.6 to 30.9	5.5 Months Interval 4.1 to 5.6

SECONDARY outcome

Timeframe: Baseline to Cycle 5; each cycle is 21 days

Population: Health-Related Quality of Life (HRQoL) analysis set included all randomized participants who received ≥ 1 dose of study drug and completed ≥ HRQoL assessment post baseline

Least squares mean change from baseline in EORTC QLQ-CL13 scores for chest pain, coughing, and dyspnea between tislelizumab arms and paclitaxel + carboplatin arm. The EORTC QLQ-LC13 is a questionnaire that measures lung cancer-specific disease and treatment symptoms. It includes questions about specific symptoms in which participants respond based on a 4-point scale, where 1 is "not at all" and 4 is "very much". Raw scores are transformed into a 0 to 100 scale via linear transformation. A lower score indicates an improvement in symptoms.

Outcome measures

Measure	Tislelizumab + Paclitaxel + Carboplatin n=120 Participants Tislelizumab 200 milligrams (mg) plus paclitaxel 175 mg/m\^2 and carboplatin area under the plasma or serum concentration-time curve (AUC) 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)	Tislelizumab + Nab-paclitaxel + Carboplatin n=118 Participants Tislelizumab 200 mg on Day 1 plus Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; Nab-paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)	Paclitaxel + Carboplatin Paclitaxel 175 mg/m\^2 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks for 4 to 6 cycles (each cycle is 21 days)
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ-LC13) Coughing	-7.0 Score on a scale Interval -14.3 to 0.2	-0.4 Score on a scale Interval -7.7 to 6.8	—
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ-LC13) Chest pain	0.4 Score on a scale Interval -5.0 to 5.9	-0.4 Score on a scale Interval -5.9 to 5.1	—
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ-LC13) Dyspnea	-2.7 Score on a scale Interval -6.9 to 1.6	-1.0 Score on a scale Interval -5.3 to 3.3	—

SECONDARY outcome

Timeframe: Baseline to Cycle 5; each cycle is 21 days

Population: HRQoL analysis set included all randomized participants who received ≥ 1 dose of study drug and completed ≥ HRQoL assessment post baseline

Least squares mean change from baseline in EORTC QLQ-C30 Global Health Status/Quality of Life score between tislelizumab arms and paclitaxel + carboplatin arm. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer patients. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes.

Outcome measures

Measure	Tislelizumab + Paclitaxel + Carboplatin n=120 Participants Tislelizumab 200 milligrams (mg) plus paclitaxel 175 mg/m\^2 and carboplatin area under the plasma or serum concentration-time curve (AUC) 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)	Tislelizumab + Nab-paclitaxel + Carboplatin n=118 Participants Tislelizumab 200 mg on Day 1 plus Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; Nab-paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)	Paclitaxel + Carboplatin Paclitaxel 175 mg/m\^2 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks for 4 to 6 cycles (each cycle is 21 days)
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status	2.4 Score on a scale Interval -3.4 to 8.2	3.3 Score on a scale Interval -2.5 to 9.2	—

SECONDARY outcome

Timeframe: From first dose to 30 days after the last dose (up to approximately 4 years and 9 months)

Population: Safety analysis set included all randomized participants who received ≥ 1 dose of any study treatment

Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), which includes laboratory tests, physical exams, electrocardiogram results and vital signs, according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0

Outcome measures

Measure	Tislelizumab + Paclitaxel + Carboplatin n=120 Participants Tislelizumab 200 milligrams (mg) plus paclitaxel 175 mg/m\^2 and carboplatin area under the plasma or serum concentration-time curve (AUC) 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)	Tislelizumab + Nab-paclitaxel + Carboplatin n=118 Participants Tislelizumab 200 mg on Day 1 plus Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; Nab-paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)	Paclitaxel + Carboplatin n=117 Participants Paclitaxel 175 mg/m\^2 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks for 4 to 6 cycles (each cycle is 21 days)
Number of Participants With Adverse Events At least 1 TEAE	120 Participants	117 Participants	117 Participants
Number of Participants With Adverse Events At least 1 SAE	56 Participants	55 Participants	29 Participants

Adverse Events

Tislelizumab + Paclitaxel + Carboplatin

Serious events: 56 serious events

Other events: 119 other events

Deaths: 78 deaths

Tislelizumab + Nab-Paclitaxel + Carboplatin

Serious events: 55 serious events

Other events: 117 other events

Deaths: 86 deaths

Paclitaxel + Carboplatin

Serious events: 29 serious events

Other events: 116 other events

Deaths: 87 deaths

Serious adverse events

Measure	Tislelizumab + Paclitaxel + Carboplatin n=120 participants at risk Tislelizumab 200 milligrams (mg) plus paclitaxel 175 mg/m\^2 and carboplatin area under the plasma or serum concentration-time curve (AUC) 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)	Tislelizumab + Nab-Paclitaxel + Carboplatin n=118 participants at risk Tislelizumab 200 mg on Day 1 plus Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; Nab-paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)	Paclitaxel + Carboplatin n=117 participants at risk Paclitaxel 175 mg/m\^2 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks for 4 to 6 cycles (each cycle is 21 days)
Respiratory, thoracic and mediastinal disorders Pneumonitis	5.0% 6/120 • Number of events 6 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	5.9% 7/118 • Number of events 7 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.83% 1/120 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/118 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Blood and lymphatic system disorders Anaemia	0.83% 1/120 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	1.7% 2/117 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Blood and lymphatic system disorders Febrile neutropenia	1.7% 2/120 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	3.4% 4/118 • Number of events 4 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/117 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Blood and lymphatic system disorders Hypofibrinogenaemia	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Blood and lymphatic system disorders Leukopenia	1.7% 2/120 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/117 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Blood and lymphatic system disorders Myelosuppression	1.7% 2/120 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Blood and lymphatic system disorders Neutropenia	0.83% 1/120 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Blood and lymphatic system disorders Splenic haemorrhage	0.83% 1/120 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/118 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Blood and lymphatic system disorders Thrombocytopenia	1.7% 2/120 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	2.6% 3/117 • Number of events 3 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Cardiac disorders Atrial fibrillation	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/118 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/117 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Cardiac disorders Immune-mediated myocarditis	0.83% 1/120 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/118 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Cardiac disorders Myocarditis	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Cardiac disorders Pericardial effusion	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Cardiac disorders Sinus tachycardia	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/118 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/117 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Endocrine disorders Autoimmune thyroiditis	0.83% 1/120 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/118 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Gastrointestinal disorders Abdominal distension	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Gastrointestinal disorders Ascites	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Gastrointestinal disorders Colitis	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Gastrointestinal disorders Diarrhoea	0.83% 1/120 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/118 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Gastrointestinal disorders Gastrointestinal haemorrhage	0.83% 1/120 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/118 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Gastrointestinal disorders Oesophageal obstruction	0.83% 1/120 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/118 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/117 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Gastrointestinal disorders Vomiting	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/117 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
General disorders Asthenia	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/118 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/117 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
General disorders Chest discomfort	0.83% 1/120 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/118 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
General disorders Cyst	0.83% 1/120 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/118 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
General disorders Death	0.83% 1/120 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	1.7% 2/118 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	1.7% 2/117 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
General disorders Fatigue	0.83% 1/120 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/118 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
General disorders Malaise	1.7% 2/120 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/118 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
General disorders Multiple organ dysfunction syndrome	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/118 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/117 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
General disorders Pain	0.83% 1/120 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/118 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
General disorders Puncture site haemorrhage	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/118 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/117 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
General disorders Pyrexia	1.7% 2/120 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	1.7% 2/117 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Hepatobiliary disorders Hepatic failure	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Hepatobiliary disorders Hepatic function abnormal	0.83% 1/120 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/117 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Hepatobiliary disorders Immune-mediated hepatitis	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Infections and infestations Appendicitis	0.83% 1/120 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/118 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Infections and infestations COVID-19 pneumonia	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Infections and infestations Infection	0.83% 1/120 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/118 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Infections and infestations Pneumocystis jirovecii pneumonia	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Infections and infestations Pneumonia	10.0% 12/120 • Number of events 15 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	5.9% 7/118 • Number of events 7 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	4.3% 5/117 • Number of events 5 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Infections and infestations Pulmonary tuberculosis	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Infections and infestations Pyelonephritis acute	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Infections and infestations Rash pustular	0.83% 1/120 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/118 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Infections and infestations Respiratory tract infection	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Infections and infestations Septic shock	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	1.7% 2/117 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Infections and infestations Tuberculous pleurisy	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Infections and infestations Upper respiratory tract infection	0.83% 1/120 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Infections and infestations Urinary tract infection	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	1.7% 2/118 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Injury, poisoning and procedural complications Cerebral radiation injury	0.83% 1/120 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/118 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Injury, poisoning and procedural complications Contusion	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Injury, poisoning and procedural complications Femur fracture	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Injury, poisoning and procedural complications Spinal compression fracture	0.83% 1/120 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/118 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Alanine aminotransferase increased	0.83% 1/120 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/118 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Aspartate aminotransferase increased	1.7% 2/120 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/118 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Blood creatine phosphokinase increased	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	1.7% 2/118 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Electrocardiogram ST-T segment abnormal	0.83% 1/120 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/118 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Neutrophil count decreased	3.3% 4/120 • Number of events 4 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	3.4% 4/118 • Number of events 5 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	1.7% 2/117 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Platelet count decreased	0.83% 1/120 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	1.7% 2/118 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations White blood cell count decreased	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	1.7% 2/117 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Metabolism and nutrition disorders Decreased appetite	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Metabolism and nutrition disorders Hypoalbuminaemia	0.83% 1/120 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/118 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 3 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Metabolism and nutrition disorders Hypoproteinaemia	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Musculoskeletal and connective tissue disorders Immune-mediated arthritis	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Musculoskeletal and connective tissue disorders Pathological fracture	0.83% 1/120 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/118 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal stromal tumour	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour benign	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Nervous system disorders Cerebral infarction	1.7% 2/120 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Nervous system disorders Cerebrovascular accident	0.83% 1/120 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/118 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Nervous system disorders Facial paralysis	0.83% 1/120 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/118 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Nervous system disorders Hydrocephalus	0.83% 1/120 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/118 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Nervous system disorders Immune-mediated encephalitis	0.83% 1/120 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/118 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Psychiatric disorders Thinking abnormal	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Renal and urinary disorders Ureterolithiasis	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Respiratory, thoracic and mediastinal disorders Bronchostenosis	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.83% 1/120 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Respiratory, thoracic and mediastinal disorders Haemoptysis	3.3% 4/120 • Number of events 5 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	3.4% 4/118 • Number of events 4 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/117 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Respiratory, thoracic and mediastinal disorders Immune-mediated lung disease	0.83% 1/120 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	1.7% 2/118 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	1.7% 2/120 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	1.7% 2/118 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/117 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Respiratory, thoracic and mediastinal disorders Laryngeal obstruction	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/118 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/117 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/118 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/117 • Number of events 3 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.83% 1/120 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Skin and subcutaneous tissue disorders Drug eruption	0.83% 1/120 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/118 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Skin and subcutaneous tissue disorders Rash	1.7% 2/120 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/118 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Skin and subcutaneous tissue disorders Rash erythematous	0.83% 1/120 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/118 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/118 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/117 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment

Other adverse events

Measure	Tislelizumab + Paclitaxel + Carboplatin n=120 participants at risk Tislelizumab 200 milligrams (mg) plus paclitaxel 175 mg/m\^2 and carboplatin area under the plasma or serum concentration-time curve (AUC) 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)	Tislelizumab + Nab-Paclitaxel + Carboplatin n=118 participants at risk Tislelizumab 200 mg on Day 1 plus Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; Nab-paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)	Paclitaxel + Carboplatin n=117 participants at risk Paclitaxel 175 mg/m\^2 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks for 4 to 6 cycles (each cycle is 21 days)
Metabolism and nutrition disorders Hypomagnesaemia	6.7% 8/120 • Number of events 13 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	7.6% 9/118 • Number of events 16 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	6.0% 7/117 • Number of events 11 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Metabolism and nutrition disorders Hyponatraemia	23.3% 28/120 • Number of events 47 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	23.7% 28/118 • Number of events 59 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	17.1% 20/117 • Number of events 29 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Blood and lymphatic system disorders Anaemia	89.2% 107/120 • Number of events 277 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	94.1% 111/118 • Number of events 297 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	80.3% 94/117 • Number of events 198 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Blood and lymphatic system disorders Leukocytosis	2.5% 3/120 • Number of events 4 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	3.4% 4/118 • Number of events 5 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	6.0% 7/117 • Number of events 11 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Blood and lymphatic system disorders Leukopenia	48.3% 58/120 • Number of events 234 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	55.9% 66/118 • Number of events 291 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	48.7% 57/117 • Number of events 187 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Blood and lymphatic system disorders Neutropenia	44.2% 53/120 • Number of events 191 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	42.4% 50/118 • Number of events 196 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	47.9% 56/117 • Number of events 160 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Blood and lymphatic system disorders Thrombocytopenia	30.0% 36/120 • Number of events 89 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	40.7% 48/118 • Number of events 131 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	28.2% 33/117 • Number of events 54 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Cardiac disorders Sinus bradycardia	1.7% 2/120 • Number of events 6 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	4.2% 5/118 • Number of events 12 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Cardiac disorders Supraventricular extrasystoles	3.3% 4/120 • Number of events 4 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	4.2% 5/118 • Number of events 14 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Cardiac disorders Ventricular extrasystoles	5.0% 6/120 • Number of events 6 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 7 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/117 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Endocrine disorders Hyperthyroidism	5.8% 7/120 • Number of events 9 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	2.5% 3/118 • Number of events 3 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Endocrine disorders Hypothyroidism	15.8% 19/120 • Number of events 42 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	13.6% 16/118 • Number of events 26 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Gastrointestinal disorders Abdominal discomfort	5.0% 6/120 • Number of events 6 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	3.4% 4/118 • Number of events 4 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	1.7% 2/117 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Gastrointestinal disorders Abdominal distension	5.0% 6/120 • Number of events 6 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	8.5% 10/118 • Number of events 12 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	2.6% 3/117 • Number of events 4 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Gastrointestinal disorders Abdominal pain	3.3% 4/120 • Number of events 4 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	3.4% 4/118 • Number of events 4 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/117 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Gastrointestinal disorders Abdominal pain upper	5.8% 7/120 • Number of events 10 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	5.9% 7/118 • Number of events 8 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	2.6% 3/117 • Number of events 3 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Gastrointestinal disorders Constipation	33.3% 40/120 • Number of events 48 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	30.5% 36/118 • Number of events 50 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	23.1% 27/117 • Number of events 30 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Gastrointestinal disorders Diarrhoea	17.5% 21/120 • Number of events 32 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	20.3% 24/118 • Number of events 41 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	6.8% 8/117 • Number of events 9 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Gastrointestinal disorders Dry mouth	3.3% 4/120 • Number of events 5 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	1.7% 2/118 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Gastrointestinal disorders Dyspepsia	0.83% 1/120 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	4.2% 5/118 • Number of events 6 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/117 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Gastrointestinal disorders Dysphagia	3.3% 4/120 • Number of events 4 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	1.7% 2/118 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/117 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Gastrointestinal disorders Nausea	30.8% 37/120 • Number of events 68 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	45.8% 54/118 • Number of events 87 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	29.9% 35/117 • Number of events 51 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Gastrointestinal disorders Oral pain	1.7% 2/120 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	3.4% 4/118 • Number of events 6 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	1.7% 2/117 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Gastrointestinal disorders Stomatitis	3.3% 4/120 • Number of events 4 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	2.5% 3/118 • Number of events 3 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Gastrointestinal disorders Toothache	3.3% 4/120 • Number of events 4 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	3.4% 4/118 • Number of events 5 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	2.6% 3/117 • Number of events 3 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Gastrointestinal disorders Vomiting	23.3% 28/120 • Number of events 41 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	22.0% 26/118 • Number of events 41 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	16.2% 19/117 • Number of events 25 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
General disorders Asthenia	25.0% 30/120 • Number of events 38 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	20.3% 24/118 • Number of events 32 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	19.7% 23/117 • Number of events 33 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
General disorders Chest discomfort	4.2% 5/120 • Number of events 5 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	4.2% 5/118 • Number of events 6 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/117 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
General disorders Chest pain	4.2% 5/120 • Number of events 6 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	3.4% 4/118 • Number of events 4 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	2.6% 3/117 • Number of events 3 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
General disorders Fatigue	4.2% 5/120 • Number of events 8 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	5.1% 6/118 • Number of events 6 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	5.1% 6/117 • Number of events 6 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
General disorders Malaise	18.3% 22/120 • Number of events 35 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	16.1% 19/118 • Number of events 32 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	16.2% 19/117 • Number of events 31 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
General disorders Non-cardiac chest pain	4.2% 5/120 • Number of events 5 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	4.2% 5/118 • Number of events 7 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	1.7% 2/117 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
General disorders Oedema peripheral	2.5% 3/120 • Number of events 5 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	5.9% 7/118 • Number of events 12 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	1.7% 2/117 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
General disorders Pain	6.7% 8/120 • Number of events 10 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	2.5% 3/118 • Number of events 3 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	5.1% 6/117 • Number of events 10 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
General disorders Pyrexia	20.8% 25/120 • Number of events 32 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	20.3% 24/118 • Number of events 40 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	14.5% 17/117 • Number of events 23 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Hepatobiliary disorders Hepatic function abnormal	5.8% 7/120 • Number of events 11 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	2.5% 3/118 • Number of events 3 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	8.5% 10/117 • Number of events 11 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Immune system disorders Drug hypersensitivity	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	2.5% 3/118 • Number of events 4 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	3.4% 4/117 • Number of events 5 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Infections and infestations Influenza	3.3% 4/120 • Number of events 4 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	1.7% 2/118 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/117 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Infections and infestations Nasopharyngitis	4.2% 5/120 • Number of events 5 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/117 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Infections and infestations Pneumonia	12.5% 15/120 • Number of events 25 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	11.0% 13/118 • Number of events 17 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	6.8% 8/117 • Number of events 10 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Infections and infestations Rash pustular	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	3.4% 4/118 • Number of events 4 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Infections and infestations Upper respiratory tract infection	16.7% 20/120 • Number of events 25 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	12.7% 15/118 • Number of events 23 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	9.4% 11/117 • Number of events 13 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Injury, poisoning and procedural complications Infusion related reaction	4.2% 5/120 • Number of events 6 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	4.2% 5/118 • Number of events 8 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	3.4% 4/117 • Number of events 7 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Alanine aminotransferase increased	47.5% 57/120 • Number of events 131 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	39.0% 46/118 • Number of events 82 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	23.1% 27/117 • Number of events 42 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Alpha hydroxybutyrate dehydrogenase increased	5.0% 6/120 • Number of events 10 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	1.7% 2/118 • Number of events 5 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	3.4% 4/117 • Number of events 8 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Aspartate aminotransferase increased	43.3% 52/120 • Number of events 120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	37.3% 44/118 • Number of events 82 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	12.0% 14/117 • Number of events 19 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Bilirubin conjugated increased	5.0% 6/120 • Number of events 9 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	3.4% 4/118 • Number of events 9 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	3.4% 4/117 • Number of events 5 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Blood albumin decreased	1.7% 2/120 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	4.2% 5/118 • Number of events 9 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	2.6% 3/117 • Number of events 4 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Blood alkaline phosphatase increased	16.7% 20/120 • Number of events 33 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	10.2% 12/118 • Number of events 21 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	9.4% 11/117 • Number of events 18 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Blood bilirubin increased	25.8% 31/120 • Number of events 94 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	17.8% 21/118 • Number of events 46 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	12.8% 15/117 • Number of events 22 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Blood bilirubin unconjugated increased	4.2% 5/120 • Number of events 9 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	4.2% 5/118 • Number of events 10 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	3.4% 4/117 • Number of events 6 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Blood chloride decreased	5.0% 6/120 • Number of events 6 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	1.7% 2/118 • Number of events 3 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	1.7% 2/117 • Number of events 3 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Blood cholesterol increased	2.5% 3/120 • Number of events 13 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	1.7% 2/118 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	3.4% 4/117 • Number of events 5 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Blood creatine phosphokinase MB increased	4.2% 5/120 • Number of events 10 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	5.1% 6/118 • Number of events 12 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/117 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Blood creatine phosphokinase decreased	3.3% 4/120 • Number of events 6 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	1.7% 2/118 • Number of events 3 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	1.7% 2/117 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Blood creatine phosphokinase increased	18.3% 22/120 • Number of events 47 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	13.6% 16/118 • Number of events 56 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	8.5% 10/117 • Number of events 14 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Blood creatinine increased	5.8% 7/120 • Number of events 12 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	9.3% 11/118 • Number of events 36 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	6.0% 7/117 • Number of events 10 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Blood fibrinogen increased	2.5% 3/120 • Number of events 3 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	3.4% 4/118 • Number of events 14 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	1.7% 2/117 • Number of events 3 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Blood glucose increased	5.0% 6/120 • Number of events 8 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	1.7% 2/118 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/117 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Blood lactate dehydrogenase increased	19.2% 23/120 • Number of events 45 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	16.9% 20/118 • Number of events 33 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	11.1% 13/117 • Number of events 20 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Blood magnesium decreased	3.3% 4/120 • Number of events 6 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	1.7% 2/118 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	1.7% 2/117 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Blood potassium decreased	0.83% 1/120 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	4.2% 5/118 • Number of events 5 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Blood thyroid stimulating hormone decreased	3.3% 4/120 • Number of events 4 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	7.6% 9/118 • Number of events 17 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/117 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Blood thyroid stimulating hormone increased	8.3% 10/120 • Number of events 15 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	7.6% 9/118 • Number of events 24 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/117 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Blood urea increased	5.8% 7/120 • Number of events 9 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	3.4% 4/118 • Number of events 5 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	3.4% 4/117 • Number of events 7 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Electrocardiogram QT prolonged	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	4.2% 5/118 • Number of events 7 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Electrocardiogram T wave abnormal	3.3% 4/120 • Number of events 6 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	3.4% 4/118 • Number of events 20 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Fibrin D dimer increased	3.3% 4/120 • Number of events 4 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	3.4% 4/118 • Number of events 10 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	2.6% 3/117 • Number of events 3 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Gamma-glutamyltransferase increased	17.5% 21/120 • Number of events 47 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	15.3% 18/118 • Number of events 30 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	12.8% 15/117 • Number of events 20 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Glomerular filtration rate decreased	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	4.2% 5/118 • Number of events 9 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Lymphocyte count decreased	13.3% 16/120 • Number of events 38 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	20.3% 24/118 • Number of events 84 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	13.7% 16/117 • Number of events 32 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Neutrophil count decreased	65.0% 78/120 • Number of events 283 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	61.9% 73/118 • Number of events 327 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	58.1% 68/117 • Number of events 220 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Neutrophil count increased	5.0% 6/120 • Number of events 7 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	4.2% 5/118 • Number of events 5 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	1.7% 2/117 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Platelet count decreased	37.5% 45/120 • Number of events 109 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	45.8% 54/118 • Number of events 137 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	24.8% 29/117 • Number of events 64 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Protein total decreased	0.83% 1/120 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	1.7% 2/118 • Number of events 13 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	4.3% 5/117 • Number of events 7 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Thyroxine free decreased	1.7% 2/120 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	5.1% 6/118 • Number of events 9 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/117 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Thyroxine free increased	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	5.1% 6/118 • Number of events 12 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Total bile acids increased	4.2% 5/120 • Number of events 6 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	4.2% 5/118 • Number of events 7 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Tri-iodothyronine free decreased	2.5% 3/120 • Number of events 3 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	3.4% 4/118 • Number of events 5 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Tri-iodothyronine free increased	0.83% 1/120 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	5.9% 7/118 • Number of events 8 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Urinary occult blood positive	0.83% 1/120 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	3.4% 4/118 • Number of events 5 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Weight decreased	12.5% 15/120 • Number of events 18 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	14.4% 17/118 • Number of events 22 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	6.8% 8/117 • Number of events 8 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations Weight increased	10.8% 13/120 • Number of events 17 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	7.6% 9/118 • Number of events 15 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	1.7% 2/117 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations White blood cell count decreased	56.7% 68/120 • Number of events 241 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	57.6% 68/118 • Number of events 291 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	52.1% 61/117 • Number of events 190 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Investigations White blood cell count increased	3.3% 4/120 • Number of events 4 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	4.2% 5/118 • Number of events 5 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	1.7% 2/117 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Metabolism and nutrition disorders Decreased appetite	45.8% 55/120 • Number of events 87 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	46.6% 55/118 • Number of events 89 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	31.6% 37/117 • Number of events 72 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Metabolism and nutrition disorders Hypercalcaemia	5.8% 7/120 • Number of events 10 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	2.5% 3/118 • Number of events 3 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	3.4% 4/117 • Number of events 5 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Metabolism and nutrition disorders Hypercholesterolaemia	6.7% 8/120 • Number of events 19 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	5.9% 7/118 • Number of events 12 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	2.6% 3/117 • Number of events 3 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Metabolism and nutrition disorders Hyperglycaemia	18.3% 22/120 • Number of events 65 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	12.7% 15/118 • Number of events 34 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	8.5% 10/117 • Number of events 14 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Metabolism and nutrition disorders Hyperkalaemia	2.5% 3/120 • Number of events 3 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	2.5% 3/118 • Number of events 7 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	3.4% 4/117 • Number of events 5 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Metabolism and nutrition disorders Hypermagnesaemia	0.83% 1/120 • Number of events 3 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	3.4% 4/118 • Number of events 5 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Metabolism and nutrition disorders Hypertriglyceridaemia	13.3% 16/120 • Number of events 30 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	6.8% 8/118 • Number of events 27 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	6.8% 8/117 • Number of events 12 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Metabolism and nutrition disorders Hyperuricaemia	15.0% 18/120 • Number of events 50 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	12.7% 15/118 • Number of events 71 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	5.1% 6/117 • Number of events 10 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Metabolism and nutrition disorders Hypoalbuminaemia	26.7% 32/120 • Number of events 56 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	22.9% 27/118 • Number of events 40 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	16.2% 19/117 • Number of events 26 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Metabolism and nutrition disorders Hypocalcaemia	12.5% 15/120 • Number of events 23 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	8.5% 10/118 • Number of events 31 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	4.3% 5/117 • Number of events 7 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Metabolism and nutrition disorders Hypochloraemia	9.2% 11/120 • Number of events 19 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	9.3% 11/118 • Number of events 17 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	9.4% 11/117 • Number of events 13 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Metabolism and nutrition disorders Hypokalaemia	22.5% 27/120 • Number of events 42 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	18.6% 22/118 • Number of events 40 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	13.7% 16/117 • Number of events 22 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Metabolism and nutrition disorders Hypophosphataemia	5.0% 6/120 • Number of events 9 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	5.9% 7/118 • Number of events 20 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	2.6% 3/117 • Number of events 3 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Metabolism and nutrition disorders Hypoproteinaemia	14.2% 17/120 • Number of events 33 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	9.3% 11/118 • Number of events 23 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	10.3% 12/117 • Number of events 25 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Musculoskeletal and connective tissue disorders Arthralgia	27.5% 33/120 • Number of events 61 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	24.6% 29/118 • Number of events 38 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	17.1% 20/117 • Number of events 40 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Musculoskeletal and connective tissue disorders Back pain	11.7% 14/120 • Number of events 17 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	16.9% 20/118 • Number of events 22 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	4.3% 5/117 • Number of events 6 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Musculoskeletal and connective tissue disorders Bone pain	1.7% 2/120 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	1.7% 2/118 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	5.1% 6/117 • Number of events 10 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Musculoskeletal and connective tissue disorders Muscular weakness	3.3% 4/120 • Number of events 7 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	5.1% 6/118 • Number of events 8 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	1.7% 2/117 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	2.5% 3/120 • Number of events 3 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	7.6% 9/118 • Number of events 9 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	2.6% 3/117 • Number of events 3 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Musculoskeletal and connective tissue disorders Myalgia	6.7% 8/120 • Number of events 9 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	6.8% 8/118 • Number of events 9 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	5.1% 6/117 • Number of events 7 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Musculoskeletal and connective tissue disorders Pain in extremity	35.0% 42/120 • Number of events 59 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	16.9% 20/118 • Number of events 35 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	23.1% 27/117 • Number of events 38 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	5.8% 7/120 • Number of events 8 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	3.4% 4/118 • Number of events 6 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	5.1% 6/117 • Number of events 6 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	2.5% 3/120 • Number of events 4 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	3.4% 4/118 • Number of events 4 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	4.3% 5/117 • Number of events 5 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Nervous system disorders Dizziness	5.0% 6/120 • Number of events 8 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	8.5% 10/118 • Number of events 11 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	5.1% 6/117 • Number of events 6 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Nervous system disorders Headache	4.2% 5/120 • Number of events 5 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	5.1% 6/118 • Number of events 7 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Nervous system disorders Hypoaesthesia	22.5% 27/120 • Number of events 35 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	11.0% 13/118 • Number of events 13 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	17.1% 20/117 • Number of events 30 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Nervous system disorders Neurotoxicity	12.5% 15/120 • Number of events 16 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	5.1% 6/118 • Number of events 6 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	10.3% 12/117 • Number of events 14 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Nervous system disorders Paraesthesia	4.2% 5/120 • Number of events 7 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Nervous system disorders Peripheral sensory neuropathy	6.7% 8/120 • Number of events 10 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	4.3% 5/117 • Number of events 6 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Psychiatric disorders Insomnia	7.5% 9/120 • Number of events 14 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	9.3% 11/118 • Number of events 13 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	12.0% 14/117 • Number of events 16 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Respiratory, thoracic and mediastinal disorders Cough	18.3% 22/120 • Number of events 28 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	16.1% 19/118 • Number of events 22 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	6.8% 8/117 • Number of events 9 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Respiratory, thoracic and mediastinal disorders Dyspnoea	15.8% 19/120 • Number of events 23 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	12.7% 15/118 • Number of events 17 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	9.4% 11/117 • Number of events 12 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/120 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	5.1% 6/118 • Number of events 6 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Respiratory, thoracic and mediastinal disorders Haemoptysis	16.7% 20/120 • Number of events 21 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	14.4% 17/118 • Number of events 23 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	11.1% 13/117 • Number of events 18 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Respiratory, thoracic and mediastinal disorders Productive cough	5.0% 6/120 • Number of events 6 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	5.1% 6/118 • Number of events 6 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	8.5% 10/117 • Number of events 10 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Respiratory, thoracic and mediastinal disorders Tachypnoea	4.2% 5/120 • Number of events 5 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/118 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.85% 1/117 • Number of events 1 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Skin and subcutaneous tissue disorders Alopecia	65.0% 78/120 • Number of events 80 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	69.5% 82/118 • Number of events 84 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	61.5% 72/117 • Number of events 73 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Skin and subcutaneous tissue disorders Dermatitis allergic	3.3% 4/120 • Number of events 4 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	1.7% 2/118 • Number of events 2 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	0.00% 0/117 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Skin and subcutaneous tissue disorders Pruritus	7.5% 9/120 • Number of events 11 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	7.6% 9/118 • Number of events 10 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	2.6% 3/117 • Number of events 4 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Skin and subcutaneous tissue disorders Rash	20.8% 25/120 • Number of events 36 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	23.7% 28/118 • Number of events 31 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	3.4% 4/117 • Number of events 5 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment
Vascular disorders Hypertension	4.2% 5/120 • Number of events 5 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	5.1% 6/118 • Number of events 10 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment	2.6% 3/117 • Number of events 6 • From the first dose up to 30 days after the last dose of study drug, up to approximately 4 years and 9 months All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment

Additional Information

Study Director

BeiGene

Phone: 1-877-828-5568

Email: clinicaltrials@beigene.com

Results disclosure agreements

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

Restriction type: OTHER