Trial Outcomes & Findings for Ociperlimab With Tislelizumab and Chemotherapy in Participants With Untreated Metastatic Non-Small Cell Lung Cancer (NCT NCT05014815)

NCT ID: NCT05014815

Last Updated: 2025-09-16

Results Overview

PFS was defined as the time from randomization to the first objectively documented disease progression as assessed by the investigator per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) or death from any cause, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 272 participants
• Primary outcome timeframe: From randomization up to the final efficacy analysis data cut-off date of 04 September 2024; Up to 33 months
• Results posted on: 2025-09-16

Participant Flow

This study was conducted at 75 study centers in 8 countries (China, South Korea, United States of America, Australia, France, Spain, Austria, Greece).

Eligible participants were randomized in a 1:1 ratio to receive either ociperlimab or placebo treatment, plus tislelizumab and chemotherapy. Randomization was stratified by histology (squamous versus non--squamous), and programmed cell death protein ligand-1 (PD-L1) expression.

Participant milestones

Measure	Arm A (O+T+C) Ociperlimab (900 mg IV), tislelizumab (200 mg IV), and histology-based chemotherapy	Arm B (P+T+C) Placebo, tislelizumab (200 mg IV), and histology-based chemotherapy
Overall Study STARTED	136	136
Overall Study Treated	135	136
Overall Study COMPLETED	57	50
Overall Study NOT COMPLETED	79	86

Reasons for withdrawal

Measure	Arm A (O+T+C) Ociperlimab (900 mg IV), tislelizumab (200 mg IV), and histology-based chemotherapy	Arm B (P+T+C) Placebo, tislelizumab (200 mg IV), and histology-based chemotherapy
Overall Study Death	63	70
Overall Study Withdrawal by Subject	10	10
Overall Study Lost to Follow-up	4	2
Overall Study Physician Decision	2	4

Baseline Characteristics

Ociperlimab With Tislelizumab and Chemotherapy in Participants With Untreated Metastatic Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Measure	Arm A (O+T+C) n=136 Participants Ociperlimab (900 mg IV), tislelizumab (200 mg IV), and histology-based chemotherapy	Arm B (P+T+C) n=136 Participants Placebo, tislelizumab (200 mg IV), and histology-based chemotherapy	Total n=272 Participants Total of all reporting groups
Race/Ethnicity, Customized Unknown	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	114 Participants n=5 Participants	104 Participants n=7 Participants	218 Participants n=5 Participants
Race/Ethnicity, Customized Asian	105 Participants n=5 Participants	102 Participants n=7 Participants	207 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White	23 Participants n=5 Participants	25 Participants n=7 Participants	48 Participants n=5 Participants
Race/Ethnicity, Customized Not Reported	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Age, Continuous	64.02 years STANDARD_DEVIATION 8.006 • n=5 Participants	63.77 years STANDARD_DEVIATION 9.366 • n=7 Participants	63.90 years STANDARD_DEVIATION 8.697 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	32 Participants n=7 Participants	54 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	123 Participants n=5 Participants	123 Participants n=7 Participants	246 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Histology Squamous	55 Participants n=5 Participants	56 Participants n=7 Participants	111 Participants n=5 Participants
Histology Non-Squamous	81 Participants n=5 Participants	80 Participants n=7 Participants	161 Participants n=5 Participants
Programmed Death-Ligand 1 (PD-L1) Expressio < 1% of tumor cells	57 Participants n=5 Participants	58 Participants n=7 Participants	115 Participants n=5 Participants
Programmed Death-Ligand 1 (PD-L1) Expressio 1-49% of Tumor Cells	42 Participants n=5 Participants	42 Participants n=7 Participants	84 Participants n=5 Participants
Programmed Death-Ligand 1 (PD-L1) Expressio > 50% of Tumor Cells	37 Participants n=5 Participants	36 Participants n=7 Participants	73 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization up to the final efficacy analysis data cut-off date of 04 September 2024; Up to 33 months

Population: Intent-To-Treat Analysis Set

PFS was defined as the time from randomization to the first objectively documented disease progression as assessed by the investigator per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) or death from any cause, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.

Outcome measures

Measure	Arm A (O+T+C) n=136 Participants Ociperlimab (900 mg IV), tislelizumab (200 mg IV), and histology-based chemotherapy	Arm B (P+T+C) n=136 Participants Placebo, tislelizumab (200 mg IV), and histology-based chemotherapy
Progression-free Survival (PFS)	8.2 Months Interval 6.2 to 10.6	8.1 Months Interval 6.0 to 10.2

SECONDARY outcome

Timeframe: From randomization up to the final efficacy analysis data cut-off date of 04 September 2024; Up to 33 months

Population: Intent-To-Treat Analysis Set

Objective response rate is defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 Tumor assessments.

CR is defined as the disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.

PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Measure	Arm A (O+T+C) n=136 Participants Ociperlimab (900 mg IV), tislelizumab (200 mg IV), and histology-based chemotherapy	Arm B (P+T+C) n=136 Participants Placebo, tislelizumab (200 mg IV), and histology-based chemotherapy
Objective Response Rate (ORR)	41.9 percentage of participants Interval 33.5 to 50.7	47.8 percentage of participants Interval 39.2 to 56.5

SECONDARY outcome

Timeframe: From randomization up to the final efficacy analysis data cut-off date of 04 September 2024; Up to 33 months

Population: The analysis included only intent-to-treat participants with a confirmed complete or partial response per RECIST v1.1.

DOR was defined as the time from the first documented objective response to documented radiological disease progression as assessed by the investigator using RECIST v1.1, or death from any cause, whichever occurred first. Median DOR was estimated using the Kaplan-Meier method.

Progressive disease is captured as at least a 20% increase in the sum of diameters of target lesions, using the smallest sum on study as the reference (including the baseline sum if it was the smallest). In addition to the 20% relative increase, the sum also had to show an absolute increase of at least 5 mm.

Outcome measures

Measure	Arm A (O+T+C) n=57 Participants Ociperlimab (900 mg IV), tislelizumab (200 mg IV), and histology-based chemotherapy	Arm B (P+T+C) n=65 Participants Placebo, tislelizumab (200 mg IV), and histology-based chemotherapy
Duration of Response (DOR)	10.4 months Interval 8.0 to 17.7	11.2 months Interval 8.1 to 13.9

SECONDARY outcome

Timeframe: From randomization up to the final efficacy analysis data cut-off date of 04 September 2024; Up to 33 months

Population: Intent-To-Treat Analysis Set

OS was defined as the time from randomization to the documented date of death for participants who died on or before the clinical cutoff date. Median OS was calculated using the Kaplan-Meier method. Data for participants who were alive at the clinical cutoff date were censored at their last known alive date, defined as either the clinical cutoff date for those still on treatment or the most recent available date confirming they were alive, whichever occurred first.

Outcome measures

Measure	Arm A (O+T+C) n=136 Participants Ociperlimab (900 mg IV), tislelizumab (200 mg IV), and histology-based chemotherapy	Arm B (P+T+C) n=136 Participants Placebo, tislelizumab (200 mg IV), and histology-based chemotherapy
Overall Survival (OS)	20.6 Months Interval 14.4 to Not estimable due to insufficient number of participants with events	19.4 Months Interval 15.4 to 23.1

SECONDARY outcome

Timeframe: From first dose of study drug to 30 days after last dose, up to the study completion date cut-off date of 04 September 2024 (up to 32.4 months)

Population: The Safety Analysis Set included all randomized participants who received at least one dose of the study drug.

The number of participants who experienced TEAEs and SAEs was reported. An adverse event refers to any unintended or unfavorable sign, symptom, or condition (including abnormal lab results) that occurs during the study, regardless of whether it is linked to the study drug. Investigators evaluated the severity of each adverse event according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.

Outcome measures

Measure	Arm A (O+T+C) n=135 Participants Ociperlimab (900 mg IV), tislelizumab (200 mg IV), and histology-based chemotherapy	Arm B (P+T+C) n=136 Participants Placebo, tislelizumab (200 mg IV), and histology-based chemotherapy
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Number of participants with any TEAEs	134 Participants	135 Participants
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Number of participants with SAEs	63 Participants	74 Participants

Adverse Events

Arm A (O+T+C)

Serious events: 63 serious events

Other events: 132 other events

Deaths: 63 deaths

Arm B (P+T+C)

Serious events: 74 serious events

Other events: 132 other events

Deaths: 70 deaths

Serious adverse events

Measure	Arm A (O+T+C) n=135 participants at risk Ociperlimab (900 mg IV), tislelizumab (200 mg IV), and histology-based chemotherapy	Arm B (P+T+C) n=136 participants at risk Placebo, tislelizumab (200 mg IV), and histology-based chemotherapy
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Metabolism and nutrition disorders Hypokalaemia	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Respiratory, thoracic and mediastinal disorders Immune-mediated lung disease	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.5% 2/135 • Number of events 3 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	1.5% 2/136 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	2.9% 4/136 • Number of events 4 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Blood and lymphatic system disorders Anaemia	3.0% 4/135 • Number of events 6 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	3.7% 5/136 • Number of events 5 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Blood and lymphatic system disorders Coagulopathy	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Blood and lymphatic system disorders Febrile neutropenia	3.0% 4/135 • Number of events 4 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	2.9% 4/136 • Number of events 5 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Blood and lymphatic system disorders Leukopenia	2.2% 3/135 • Number of events 4 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Blood and lymphatic system disorders Neutropenia	1.5% 2/135 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	1.5% 2/136 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Blood and lymphatic system disorders Thrombocytopenia	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	1.5% 2/136 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Cardiac disorders Acute myocardial infarction	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Cardiac disorders Atrial fibrillation	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Cardiac disorders Cardiopulmonary failure	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Cardiac disorders Immune-mediated myocarditis	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	1.5% 2/136 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Cardiac disorders Myocardial infarction	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Cardiac disorders Pericardial effusion	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Cardiac disorders Tachycardia	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Abdominal pain	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Diarrhoea	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	1.5% 2/136 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Duodenal ulcer	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Gastric haemorrhage	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Gastrointestinal inflammation	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Immune-mediated enterocolitis	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	2.2% 3/136 • Number of events 4 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Immune-mediated pancreatitis	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Intra-abdominal fluid collection	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Nausea	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	1.5% 2/136 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Vomiting	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
General disorders Asthenia	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
General disorders Chest discomfort	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
General disorders Chills	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
General disorders Death	1.5% 2/135 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
General disorders Face oedema	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
General disorders Fatigue	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
General disorders General physical health deterioration	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
General disorders Generalised oedema	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
General disorders Multiple organ dysfunction syndrome	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
General disorders Non-cardiac chest pain	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
General disorders Oedema peripheral	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
General disorders Pain	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
General disorders Pyrexia	3.7% 5/135 • Number of events 6 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	1.5% 2/136 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Hepatobiliary disorders Acute hepatic failure	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Hepatobiliary disorders Cholecystitis	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Hepatobiliary disorders Cholecystitis acute	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Hepatobiliary disorders Hepatic failure	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Hepatobiliary disorders Hepatitis	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Hepatobiliary disorders Immune-mediated hepatitis	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations Bronchitis	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations COVID-19	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations COVID-19 pneumonia	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	2.9% 4/136 • Number of events 5 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations Cellulitis	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations Clostridium difficile infection	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations Focal peritonitis	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations Haematological infection	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations Influenza	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	1.5% 2/136 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations Kidney infection	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations Klebsiella sepsis	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations Lung abscess	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations Neutropenic sepsis	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations Pneumonia	7.4% 10/135 • Number of events 10 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	9.6% 13/136 • Number of events 15 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations Pneumonia staphylococcal	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations Pulmonary tuberculosis	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations Respiratory tract infection	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations Sepsis	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	1.5% 2/136 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations Septic shock	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations Upper respiratory tract infection	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations Urinary tract infection	1.5% 2/135 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Alanine aminotransferase increased	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Aspartate aminotransferase increased	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Blood bilirubin increased	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Blood creatinine increased	1.5% 2/135 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Neutrophil count decreased	3.7% 5/135 • Number of events 7 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	2.2% 3/136 • Number of events 3 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Platelet count decreased	2.2% 3/135 • Number of events 5 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	3.7% 5/136 • Number of events 5 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Troponin increased	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Weight decreased	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Investigations White blood cell count decreased	3.7% 5/135 • Number of events 6 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	2.9% 4/136 • Number of events 4 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Metabolism and nutrition disorders Decreased appetite	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Metabolism and nutrition disorders Electrolyte imbalance	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Musculoskeletal and connective tissue disorders Immune-mediated myositis	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Musculoskeletal and connective tissue disorders Myalgia	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Nervous system disorders Brain oedema	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Nervous system disorders Cerebral infarction	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Nervous system disorders Haemorrhage intracranial	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Nervous system disorders Immune-mediated encephalitis	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Nervous system disorders Lacunar infarction	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Renal and urinary disorders Acute kidney injury	0.74% 1/135 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Renal and urinary disorders Chronic kidney disease	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Renal and urinary disorders Immune-mediated nephritis	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Respiratory, thoracic and mediastinal disorders Cough	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.2% 3/135 • Number of events 3 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Respiratory, thoracic and mediastinal disorders Haemoptysis	2.2% 3/135 • Number of events 3 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	1.5% 2/136 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary artery thrombosis	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.0% 4/135 • Number of events 4 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Respiratory, thoracic and mediastinal disorders Respiratory failure	3.7% 5/135 • Number of events 5 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Skin and subcutaneous tissue disorders Immune-mediated dermatitis	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Skin and subcutaneous tissue disorders Pruritus	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Skin and subcutaneous tissue disorders Pseudocellulitis	0.74% 1/135 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.00% 0/136 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Vascular disorders Hypotension	1.5% 2/135 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Vascular disorders Venous thrombosis limb	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.

Other adverse events

Measure	Arm A (O+T+C) n=135 participants at risk Ociperlimab (900 mg IV), tislelizumab (200 mg IV), and histology-based chemotherapy	Arm B (P+T+C) n=136 participants at risk Placebo, tislelizumab (200 mg IV), and histology-based chemotherapy
Metabolism and nutrition disorders Hypoalbuminaemia	22.2% 30/135 • Number of events 53 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	16.9% 23/136 • Number of events 34 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Metabolism and nutrition disorders Hypocalcaemia	5.2% 7/135 • Number of events 10 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	4.4% 6/136 • Number of events 9 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Metabolism and nutrition disorders Hypokalaemia	17.0% 23/135 • Number of events 36 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	12.5% 17/136 • Number of events 24 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Blood and lymphatic system disorders Anaemia	66.7% 90/135 • Number of events 175 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	59.6% 81/136 • Number of events 142 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Blood and lymphatic system disorders Leukopenia	8.1% 11/135 • Number of events 42 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	9.6% 13/136 • Number of events 40 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Blood and lymphatic system disorders Lymphopenia	2.2% 3/135 • Number of events 11 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	3.7% 5/136 • Number of events 20 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Blood and lymphatic system disorders Neutropenia	8.9% 12/135 • Number of events 19 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	8.1% 11/136 • Number of events 21 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Blood and lymphatic system disorders Thrombocytopenia	9.6% 13/135 • Number of events 17 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	5.9% 8/136 • Number of events 22 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Cardiac disorders Supraventricular extrasystoles	3.7% 5/135 • Number of events 5 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	2.9% 4/136 • Number of events 7 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Endocrine disorders Hyperthyroidism	7.4% 10/135 • Number of events 12 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	5.9% 8/136 • Number of events 10 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Endocrine disorders Hypothyroidism	15.6% 21/135 • Number of events 23 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	11.8% 16/136 • Number of events 18 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Eye disorders Lacrimation increased	4.4% 6/135 • Number of events 6 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Abdominal pain	3.7% 5/135 • Number of events 5 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	9.6% 13/136 • Number of events 14 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Constipation	33.3% 45/135 • Number of events 65 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	29.4% 40/136 • Number of events 56 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Diarrhoea	15.6% 21/135 • Number of events 27 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	18.4% 25/136 • Number of events 28 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Gastrooesophageal reflux disease	3.0% 4/135 • Number of events 6 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	3.7% 5/136 • Number of events 5 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Nausea	28.1% 38/135 • Number of events 50 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	37.5% 51/136 • Number of events 98 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Stomatitis	10.4% 14/135 • Number of events 15 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	5.9% 8/136 • Number of events 8 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Gastrointestinal disorders Vomiting	17.8% 24/135 • Number of events 36 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	22.1% 30/136 • Number of events 59 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
General disorders Asthenia	8.9% 12/135 • Number of events 19 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	13.2% 18/136 • Number of events 28 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
General disorders Fatigue	20.0% 27/135 • Number of events 40 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	17.6% 24/136 • Number of events 31 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
General disorders Malaise	2.2% 3/135 • Number of events 3 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	6.6% 9/136 • Number of events 9 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
General disorders Oedema peripheral	8.1% 11/135 • Number of events 13 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	14.0% 19/136 • Number of events 22 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
General disorders Pyrexia	13.3% 18/135 • Number of events 22 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	14.7% 20/136 • Number of events 30 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations COVID-19	14.8% 20/135 • Number of events 24 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	11.0% 15/136 • Number of events 24 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations Pneumonia	8.9% 12/135 • Number of events 18 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	10.3% 14/136 • Number of events 14 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations Upper respiratory tract infection	6.7% 9/135 • Number of events 11 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	6.6% 9/136 • Number of events 11 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Infections and infestations Urinary tract infection	3.0% 4/135 • Number of events 4 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	3.7% 5/136 • Number of events 6 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Alanine aminotransferase increased	30.4% 41/135 • Number of events 69 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	31.6% 43/136 • Number of events 67 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Aspartate aminotransferase increased	29.6% 40/135 • Number of events 75 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	27.2% 37/136 • Number of events 57 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Bilirubin conjugated increased	3.0% 4/135 • Number of events 5 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	4.4% 6/136 • Number of events 6 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Blood alkaline phosphatase increased	3.0% 4/135 • Number of events 6 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	4.4% 6/136 • Number of events 9 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Blood bilirubin increased	5.9% 8/135 • Number of events 17 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	10.3% 14/136 • Number of events 15 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Blood creatine phosphokinase increased	2.2% 3/135 • Number of events 4 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	4.4% 6/136 • Number of events 6 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Blood creatinine increased	7.4% 10/135 • Number of events 10 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	16.2% 22/136 • Number of events 25 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Blood lactate dehydrogenase increased	8.1% 11/135 • Number of events 19 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	5.9% 8/136 • Number of events 10 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Blood urea increased	2.2% 3/135 • Number of events 4 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	3.7% 5/136 • Number of events 5 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Fibrin D dimer increased	3.7% 5/135 • Number of events 6 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	1.5% 2/136 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Gamma-glutamyltransferase increased	3.7% 5/135 • Number of events 8 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	9.6% 13/136 • Number of events 17 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Lymphocyte count decreased	16.3% 22/135 • Number of events 52 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	8.8% 12/136 • Number of events 47 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Neutrophil count decreased	43.7% 59/135 • Number of events 188 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	36.8% 50/136 • Number of events 175 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Neutrophil count increased	3.0% 4/135 • Number of events 6 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	3.7% 5/136 • Number of events 7 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Platelet count decreased	37.8% 51/135 • Number of events 107 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	27.2% 37/136 • Number of events 64 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Investigations SARS-CoV-2 test positive	9.6% 13/135 • Number of events 15 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	11.8% 16/136 • Number of events 17 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Weight decreased	11.9% 16/135 • Number of events 20 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	13.2% 18/136 • Number of events 18 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Investigations Weight increased	13.3% 18/135 • Number of events 23 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	10.3% 14/136 • Number of events 17 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Investigations White blood cell count decreased	45.2% 61/135 • Number of events 196 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	39.7% 54/136 • Number of events 166 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Metabolism and nutrition disorders Decreased appetite	27.4% 37/135 • Number of events 42 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	30.9% 42/136 • Number of events 55 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Metabolism and nutrition disorders Dehydration	3.0% 4/135 • Number of events 25 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	4.4% 6/136 • Number of events 40 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Metabolism and nutrition disorders Hypercholesterolaemia	3.7% 5/135 • Number of events 8 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	0.74% 1/136 • Number of events 3 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Metabolism and nutrition disorders Hyperglycaemia	9.6% 13/135 • Number of events 28 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	11.8% 16/136 • Number of events 19 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Metabolism and nutrition disorders Hypertriglyceridaemia	5.2% 7/135 • Number of events 21 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	3.7% 5/136 • Number of events 8 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Metabolism and nutrition disorders Hyperuricaemia	2.2% 3/135 • Number of events 4 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	5.9% 8/136 • Number of events 18 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Metabolism and nutrition disorders Hypomagnesaemia	4.4% 6/135 • Number of events 11 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	4.4% 6/136 • Number of events 8 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Metabolism and nutrition disorders Hyponatraemia	14.8% 20/135 • Number of events 36 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	15.4% 21/136 • Number of events 26 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Metabolism and nutrition disorders Hypophosphataemia	3.7% 5/135 • Number of events 5 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	2.9% 4/136 • Number of events 4 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	4.4% 6/135 • Number of events 10 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	7.4% 10/136 • Number of events 13 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Musculoskeletal and connective tissue disorders Back pain	5.9% 8/135 • Number of events 8 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	5.9% 8/136 • Number of events 8 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Musculoskeletal and connective tissue disorders Muscular weakness	5.2% 7/135 • Number of events 7 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	3.7% 5/136 • Number of events 5 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Musculoskeletal and connective tissue disorders Myalgia	3.7% 5/135 • Number of events 8 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	3.7% 5/136 • Number of events 6 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	7.4% 10/135 • Number of events 18 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	6.6% 9/136 • Number of events 10 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	2.2% 3/135 • Number of events 3 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	4.4% 6/136 • Number of events 6 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Nervous system disorders Dizziness	8.9% 12/135 • Number of events 16 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	5.1% 7/136 • Number of events 7 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Nervous system disorders Dysgeusia	5.2% 7/135 • Number of events 7 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	2.9% 4/136 • Number of events 5 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Nervous system disorders Headache	8.9% 12/135 • Number of events 16 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	8.8% 12/136 • Number of events 13 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Nervous system disorders Hypoaesthesia	5.2% 7/135 • Number of events 7 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	1.5% 2/136 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Nervous system disorders Paraesthesia	0.00% 0/135 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	3.7% 5/136 • Number of events 5 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Nervous system disorders Peripheral sensory neuropathy	5.9% 8/135 • Number of events 8 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	8.8% 12/136 • Number of events 13 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Psychiatric disorders Anxiety	1.5% 2/135 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	3.7% 5/136 • Number of events 5 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Psychiatric disorders Insomnia	11.9% 16/135 • Number of events 17 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	9.6% 13/136 • Number of events 13 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Respiratory, thoracic and mediastinal disorders Cough	18.5% 25/135 • Number of events 32 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	15.4% 21/136 • Number of events 23 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.4% 14/135 • Number of events 18 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	8.8% 12/136 • Number of events 13 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Respiratory, thoracic and mediastinal disorders Haemoptysis	5.9% 8/135 • Number of events 17 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	5.9% 8/136 • Number of events 8 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	4.4% 6/135 • Number of events 6 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	2.2% 3/136 • Number of events 3 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Respiratory, thoracic and mediastinal disorders Productive cough	8.1% 11/135 • Number of events 12 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	5.9% 8/136 • Number of events 9 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Skin and subcutaneous tissue disorders Alopecia	18.5% 25/135 • Number of events 25 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	19.1% 26/136 • Number of events 28 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Skin and subcutaneous tissue disorders Pruritus	21.5% 29/135 • Number of events 44 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	5.9% 8/136 • Number of events 10 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Skin and subcutaneous tissue disorders Rash	31.1% 42/135 • Number of events 62 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	19.9% 27/136 • Number of events 43 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	3.7% 5/135 • Number of events 5 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	2.9% 4/136 • Number of events 4 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Vascular disorders Hypertension	3.0% 4/135 • Number of events 4 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	3.7% 5/136 • Number of events 5 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.
Vascular disorders Hypotension	4.4% 6/135 • Number of events 6 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on all randomized participants who received ≥ 1 dose of any study treatment.	2.2% 3/136 • Number of events 3 • All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months. All-cause mortality is reported for all randomized participants. Serious and other adverse events are based on 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