Trial Outcomes & Findings for Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Plus Chemotherapy in Participants With Metastatic Esophageal Carcinoma (MK-7902-014/E7080-G000-320/LEAP-014). (NCT NCT04949256)

Last Updated: 2026-08-21

Results Overview

A DLT is defined as a specific adverse event graded for toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Hematologic DLTs are defined as Grade 4 neutropenia lasting for ≥7 days, Grade 3 or Grade 4 febrile neutropenia, Grade 3 thrombocytopenia with bleeding, Grade 4 thrombocytopenia, or Grade 4 anemia. Other nonhematologic toxicities considered a DLT include any other Grade 4 or Grade 5 toxicity, Grade 3 toxicities lasting \>3 days (excluding nausea, vomiting, and diarrhea controlled by medical intervention within 72 hours, and Grade 3 rash in the absence of desquamation with no mucosal involvement), Grade 3 hypertension not able to be controlled by medication, ≥Grade 3 gastrointestinal perforation, ≥Grade 3 wound dehiscence requiring medical or surgical intervention, any grade thromboembolic event or any Grade 3 nonhematologic laboratory value requiring medical intervention or hospitalization. The number of participants in Part 1 with DLTs are presented.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

863 participants

Primary outcome timeframe

Up to 21 days

Results posted on

2026-08-21

Participant Flow

Participants with the following conditions were included in the study: if they had a confirmed diagnosis of metastatic squamous cell carcinoma of the esophagus and measurable disease; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; submitted a tumor tissue sample; had adequately controlled blood pressure; and had adequate organ function.

Protocol-specified final analysis for the following results, including the participant flow, was performed with 368 participants ongoing in the study at the time of primary completion data cut-off. All remaining analysis of the 368 ongoing participants will be included in the End of Trial analysis.

Participant milestones

Participant milestones
Measure	Part 1: Pembrolizumab + Lenvatinib + Chemotherapy In the Induction phase, participants received pembrolizumab 400 mg intravenously (IV) every 6 weeks (Q6W) for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg orally (PO) once daily (QD) plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations at the investigator's discretion (approximately 12 weeks). In the Consolidation phase, participants received pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks).	Part 2: Pembrolizumab + Lenvatinib + Chemotherapy In the Induction phase, participants received pembrolizumab 400 mg IV Q6W for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg PO QD plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 4000 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations or mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2, and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] once every 2 weeks \[Q2W\] for 6 administrations at the investigator's discretion (approximately 12 weeks). In the Consolidation phase, participants received pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks).	Part 2: Pembrolizumab + Chemotherapy Participants received pembrolizumab 400 mg IV every 6 weeks for 18 cycles (each cycle length = 6 weeks, approximately 2 years) plus chemotherapy with FP (cisplatin 80 mg/m\^2 IV Q3W for up to 6 administrations \[up to \~18 weeks\] and 5-FU 4000 mg/m\^2 IV Q3W for up to 35 administrations \[up to \~2 years\]) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2 Q3W for up 6 administrations \[up to \~18 weeks\]) or in combination with mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2 and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] IV Q2W for up to 52 administrations \[approximately 2 years\]).
Overall Study STARTED	13	423	427
Overall Study First Course	13	421	426
Overall Study Second Course	0	1	0
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	13	423	427

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1: Pembrolizumab + Lenvatinib + Chemotherapy In the Induction phase, participants received pembrolizumab 400 mg intravenously (IV) every 6 weeks (Q6W) for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg orally (PO) once daily (QD) plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations at the investigator's discretion (approximately 12 weeks). In the Consolidation phase, participants received pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks).	Part 2: Pembrolizumab + Lenvatinib + Chemotherapy In the Induction phase, participants received pembrolizumab 400 mg IV Q6W for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg PO QD plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 4000 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations or mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2, and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] once every 2 weeks \[Q2W\] for 6 administrations at the investigator's discretion (approximately 12 weeks). In the Consolidation phase, participants received pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks).	Part 2: Pembrolizumab + Chemotherapy Participants received pembrolizumab 400 mg IV every 6 weeks for 18 cycles (each cycle length = 6 weeks, approximately 2 years) plus chemotherapy with FP (cisplatin 80 mg/m\^2 IV Q3W for up to 6 administrations \[up to \~18 weeks\] and 5-FU 4000 mg/m\^2 IV Q3W for up to 35 administrations \[up to \~2 years\]) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2 Q3W for up 6 administrations \[up to \~18 weeks\]) or in combination with mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2 and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] IV Q2W for up to 52 administrations \[approximately 2 years\]).
Overall Study Death	12	234	240
Overall Study Physician Decision	0	0	2
Overall Study Withdrawal by Subject	0	3	4
Overall Study Ongoing	1	186	181

Baseline Characteristics

Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Plus Chemotherapy in Participants With Metastatic Esophageal Carcinoma (MK-7902-014/E7080-G000-320/LEAP-014).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: Pembrolizumab + Lenvatinib + Chemotherapy n=13 Participants In the Induction phase, participants received pembrolizumab 400 mg IV Q6W for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg PO QD plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations at the investigator's discretion (approximately 12 weeks). In the Consolidation phase, participants received pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks).	Part 2: Pembrolizumab + Lenvatinib + Chemotherapy n=423 Participants In the Induction phase, participants received pembrolizumab 400 mg IV Q6W for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg PO QD plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 4000 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations or mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2, and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] once every 2 weeks \[Q2W\] for 6 administrations at the investigator's discretion (approximately 12 weeks). In the Consolidation phase, participants received pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks).	Part 2: Pembrolizumab + Chemotherapy n=427 Participants Participants received pembrolizumab 400 mg IV every 6 weeks for 18 cycles (each cycle length = 6 weeks, approximately 2 years) plus chemotherapy with FP (cisplatin 80 mg/m\^2 IV Q3W for up to 6 administrations \[up to \~18 weeks\] and 5-FU 4000 mg/m\^2 IV Q3W for up to 35 administrations \[up to \~2 years\]) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2 Q3W for up 6 administrations \[up to \~18 weeks\]) or in combination with mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2 and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] IV Q2W for up to 52 administrations \[approximately 2 years\]).	Total n=863 Participants Total of all reporting groups
Sex: Female, Male Female	0 Participants n=5 Participants	92 Participants n=109 Participants	93 Participants n=133 Participants	185 Participants n=86 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	331 Participants n=109 Participants	334 Participants n=133 Participants	678 Participants n=86 Participants
Age, Continuous	62.7 Years STANDARD_DEVIATION 10.0 • n=5 Participants	63.5 Years STANDARD_DEVIATION 9.0 • n=109 Participants	65.0 Years STANDARD_DEVIATION 8.2 • n=133 Participants	64.2 Years STANDARD_DEVIATION 8.7 • n=86 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	39 Participants n=109 Participants	56 Participants n=133 Participants	96 Participants n=86 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	378 Participants n=109 Participants	368 Participants n=133 Participants	758 Participants n=86 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	6 Participants n=109 Participants	3 Participants n=133 Participants	9 Participants n=86 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	6 Participants n=109 Participants	8 Participants n=133 Participants	14 Participants n=86 Participants
Race (NIH/OMB) Asian	11 Participants n=5 Participants	279 Participants n=109 Participants	285 Participants n=133 Participants	575 Participants n=86 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=109 Participants	0 Participants n=133 Participants	0 Participants n=86 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=109 Participants	3 Participants n=133 Participants	4 Participants n=86 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	131 Participants n=109 Participants	130 Participants n=133 Participants	263 Participants n=86 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	3 Participants n=109 Participants	1 Participants n=133 Participants	4 Participants n=86 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	3 Participants n=109 Participants	0 Participants n=133 Participants	3 Participants n=86 Participants
Region of Enrolling Site East Asia	11 Participants n=5 Participants	278 Participants n=109 Participants	281 Participants n=133 Participants	570 Participants n=86 Participants
Region of Enrolling Site North America +Western Europe	1 Participants n=5 Participants	69 Participants n=109 Participants	66 Participants n=133 Participants	136 Participants n=86 Participants
Region of Enrolling Site Rest of World	1 Participants n=5 Participants	76 Participants n=109 Participants	80 Participants n=133 Participants	157 Participants n=86 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG 0	3 Participants n=5 Participants	147 Participants n=109 Participants	168 Participants n=133 Participants	318 Participants n=86 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG 1	10 Participants n=5 Participants	273 Participants n=109 Participants	257 Participants n=133 Participants	540 Participants n=86 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status Missing	0 Participants n=5 Participants	3 Participants n=109 Participants	2 Participants n=133 Participants	5 Participants n=86 Participants

PRIMARY outcome

Timeframe: Up to 21 days

Population: All randomized participants from Part 1 who received at least 1 dose of study intervention. Per protocol participants from Part 2 were not analyzed.

Outcome measures

Outcome measures
Measure	Part 1: Pembrolizumab + Lenvatinib + Chemotherapy n=13 Participants In the Induction phase, participants received pembrolizumab 400 mg IV Q6W for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg PO QD plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations at the investigator's discretion (approximately 12 weeks). In the Consolidation phase, participants received pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks).	Part 2: Pembrolizumab + Lenvatinib + Chemotherapy In the Induction phase, participants received pembrolizumab 400 mg IV Q6W for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg PO QD plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 4000 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations or mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2, and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] once every 2 weeks \[Q2W\] for 6 administrations at the investigator's discretion (approximately 12 weeks). In the Consolidation phase, participants received pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks).	Part 2: Pembrolizumab + Chemotherapy Participants received pembrolizumab 400 mg IV every 6 weeks for 18 cycles (each cycle length = 6 weeks, approximately 2 years) plus chemotherapy with FP (cisplatin 80 mg/m\^2 IV Q3W for up to 6 administrations \[up to \~18 weeks\] and 5-FU 4000 mg/m\^2 IV Q3W for up to 35 administrations \[up to \~2 years\]) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2 Q3W for up 6 administrations \[up to \~18 weeks\]) or in combination with mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2 and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] IV Q2W for up to 52 administrations \[approximately 2 years\]).
Part 1 (FP and TP Safety Run-in): Number of Participants With Dose Limiting Toxicities (DLTs)	2 Participants	—	—

PRIMARY outcome

Timeframe: Up to 43 months

Population: All randomized participants from Part 1 who received at least 1 dose of study intervention. Per protocol participants from Part 2 were not analyzed.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants in Part 1 with AEs will be presented.

Outcome measures

Outcome measures
Measure	Part 1: Pembrolizumab + Lenvatinib + Chemotherapy n=13 Participants In the Induction phase, participants received pembrolizumab 400 mg IV Q6W for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg PO QD plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations at the investigator's discretion (approximately 12 weeks). In the Consolidation phase, participants received pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks).	Part 2: Pembrolizumab + Lenvatinib + Chemotherapy In the Induction phase, participants received pembrolizumab 400 mg IV Q6W for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg PO QD plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 4000 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations or mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2, and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] once every 2 weeks \[Q2W\] for 6 administrations at the investigator's discretion (approximately 12 weeks). In the Consolidation phase, participants received pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks).	Part 2: Pembrolizumab + Chemotherapy Participants received pembrolizumab 400 mg IV every 6 weeks for 18 cycles (each cycle length = 6 weeks, approximately 2 years) plus chemotherapy with FP (cisplatin 80 mg/m\^2 IV Q3W for up to 6 administrations \[up to \~18 weeks\] and 5-FU 4000 mg/m\^2 IV Q3W for up to 35 administrations \[up to \~2 years\]) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2 Q3W for up 6 administrations \[up to \~18 weeks\]) or in combination with mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2 and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] IV Q2W for up to 52 administrations \[approximately 2 years\]).
Part 1 (FP and TP Safety Run-in): Number of Participants With Adverse Events (AEs)	13 Participants	—	—

PRIMARY outcome

Timeframe: Up to 22 months

Population: All randomized participants from Part 1 who received at least 1 dose of study intervention. Per protocol participants from Part 2 were not analyzed.

Outcome measures

Outcome measures
Measure	Part 1: Pembrolizumab + Lenvatinib + Chemotherapy n=13 Participants In the Induction phase, participants received pembrolizumab 400 mg IV Q6W for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg PO QD plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations at the investigator's discretion (approximately 12 weeks). In the Consolidation phase, participants received pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks).	Part 2: Pembrolizumab + Lenvatinib + Chemotherapy In the Induction phase, participants received pembrolizumab 400 mg IV Q6W for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg PO QD plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 4000 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations or mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2, and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] once every 2 weeks \[Q2W\] for 6 administrations at the investigator's discretion (approximately 12 weeks). In the Consolidation phase, participants received pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks).	Part 2: Pembrolizumab + Chemotherapy Participants received pembrolizumab 400 mg IV every 6 weeks for 18 cycles (each cycle length = 6 weeks, approximately 2 years) plus chemotherapy with FP (cisplatin 80 mg/m\^2 IV Q3W for up to 6 administrations \[up to \~18 weeks\] and 5-FU 4000 mg/m\^2 IV Q3W for up to 35 administrations \[up to \~2 years\]) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2 Q3W for up 6 administrations \[up to \~18 weeks\]) or in combination with mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2 and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] IV Q2W for up to 52 administrations \[approximately 2 years\]).
Part 1 (FP and TP Safety Run-in): Number of Participants Who Discontinued Study Treatment Due to an AE	7 Participants	—	—

PRIMARY outcome

Timeframe: Up to 42 months

Population: Randomized participants in Part 2 who were analyzed according to the group assigned at randomization. Per protocol participants in Part 1 were excluded from analysis.

OS is defined as the time from randomization to death due to any cause. OS in Part 2 for all randomized participants are presented based on the Kaplan-Meier method for censored data.

Outcome measures

Outcome measures
Measure	Part 1: Pembrolizumab + Lenvatinib + Chemotherapy In the Induction phase, participants received pembrolizumab 400 mg IV Q6W for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg PO QD plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations at the investigator's discretion (approximately 12 weeks). In the Consolidation phase, participants received pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks).	Part 2: Pembrolizumab + Lenvatinib + Chemotherapy n=423 Participants In the Induction phase, participants received pembrolizumab 400 mg IV Q6W for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg PO QD plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 4000 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations or mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2, and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] once every 2 weeks \[Q2W\] for 6 administrations at the investigator's discretion (approximately 12 weeks). In the Consolidation phase, participants received pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks).	Part 2: Pembrolizumab + Chemotherapy n=427 Participants Participants received pembrolizumab 400 mg IV every 6 weeks for 18 cycles (each cycle length = 6 weeks, approximately 2 years) plus chemotherapy with FP (cisplatin 80 mg/m\^2 IV Q3W for up to 6 administrations \[up to \~18 weeks\] and 5-FU 4000 mg/m\^2 IV Q3W for up to 35 administrations \[up to \~2 years\]) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2 Q3W for up 6 administrations \[up to \~18 weeks\]) or in combination with mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2 and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] IV Q2W for up to 52 administrations \[approximately 2 years\]).
Part 2 (Main Study): Overall Survival (OS) in All Participants	—	17.6 Months Interval 15.5 to 19.1	15.5 Months Interval 13.5 to 17.2

SECONDARY outcome

Timeframe: Up to 42 months

Population: Randomized participants in Part 2 who were analyzed according to the group assigned at randomization. Per protocol participants in Part 1 were excluded from analysis.

PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. RECIST 1.1 has been adjusted to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. PFS in Part 2 for all randomized participants are presented based on the Kaplan-Meier method for censored data.

Outcome measures

Outcome measures
Measure	Part 1: Pembrolizumab + Lenvatinib + Chemotherapy In the Induction phase, participants received pembrolizumab 400 mg IV Q6W for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg PO QD plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations at the investigator's discretion (approximately 12 weeks). In the Consolidation phase, participants received pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks).	Part 2: Pembrolizumab + Lenvatinib + Chemotherapy n=423 Participants In the Induction phase, participants received pembrolizumab 400 mg IV Q6W for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg PO QD plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 4000 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations or mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2, and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] once every 2 weeks \[Q2W\] for 6 administrations at the investigator's discretion (approximately 12 weeks). In the Consolidation phase, participants received pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks).	Part 2: Pembrolizumab + Chemotherapy n=427 Participants Participants received pembrolizumab 400 mg IV every 6 weeks for 18 cycles (each cycle length = 6 weeks, approximately 2 years) plus chemotherapy with FP (cisplatin 80 mg/m\^2 IV Q3W for up to 6 administrations \[up to \~18 weeks\] and 5-FU 4000 mg/m\^2 IV Q3W for up to 35 administrations \[up to \~2 years\]) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2 Q3W for up 6 administrations \[up to \~18 weeks\]) or in combination with mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2 and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] IV Q2W for up to 52 administrations \[approximately 2 years\]).
Part 2 (Main Study): Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in All Participants	—	7.2 Months Interval 6.8 to 8.4	6.9 Months Interval 5.8 to 7.0

SECONDARY outcome

Timeframe: Up to 42 months

Population: Randomized participants in Part 2 who were analyzed according to the group assigned at randomization. Per protocol participants in Part 1 were excluded from analysis.

ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions), per RECIST 1.1 adjusted to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, as assessed by BICR. ORR in Part 2 for all randomized participants are presented.

Outcome measures

Outcome measures
Measure	Part 1: Pembrolizumab + Lenvatinib + Chemotherapy In the Induction phase, participants received pembrolizumab 400 mg IV Q6W for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg PO QD plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations at the investigator's discretion (approximately 12 weeks). In the Consolidation phase, participants received pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks).	Part 2: Pembrolizumab + Lenvatinib + Chemotherapy n=423 Participants In the Induction phase, participants received pembrolizumab 400 mg IV Q6W for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg PO QD plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 4000 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations or mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2, and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] once every 2 weeks \[Q2W\] for 6 administrations at the investigator's discretion (approximately 12 weeks). In the Consolidation phase, participants received pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks).	Part 2: Pembrolizumab + Chemotherapy n=427 Participants Participants received pembrolizumab 400 mg IV every 6 weeks for 18 cycles (each cycle length = 6 weeks, approximately 2 years) plus chemotherapy with FP (cisplatin 80 mg/m\^2 IV Q3W for up to 6 administrations \[up to \~18 weeks\] and 5-FU 4000 mg/m\^2 IV Q3W for up to 35 administrations \[up to \~2 years\]) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2 Q3W for up 6 administrations \[up to \~18 weeks\]) or in combination with mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2 and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] IV Q2W for up to 52 administrations \[approximately 2 years\]).
Part 2 (Main Study): Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR in All Participants	—	62.2 Percentage of participants Interval 57.4 to 66.8	54.8 Percentage of participants Interval 49.9 to 59.6

SECONDARY outcome

Timeframe: Up to 42 months

Population: Randomized participants in Part 2 who were analyzed according to the group assigned at randomization. Per protocol participants in Part 1 were excluded from analysis.

For participants who demonstrate a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), per RECIST 1.1 by BICR, DOR is defined as the time from first documented evidence of CR or PR until PD or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. RECIST 1.1 has been adjusted to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. DOR in Part 2 for all randomized participants are presented based on the Kaplan-Meier method for censored data.

Outcome measures

Outcome measures
Measure	Part 1: Pembrolizumab + Lenvatinib + Chemotherapy In the Induction phase, participants received pembrolizumab 400 mg IV Q6W for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg PO QD plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations at the investigator's discretion (approximately 12 weeks). In the Consolidation phase, participants received pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks).	Part 2: Pembrolizumab + Lenvatinib + Chemotherapy n=423 Participants In the Induction phase, participants received pembrolizumab 400 mg IV Q6W for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg PO QD plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 4000 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations or mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2, and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] once every 2 weeks \[Q2W\] for 6 administrations at the investigator's discretion (approximately 12 weeks). In the Consolidation phase, participants received pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks).	Part 2: Pembrolizumab + Chemotherapy n=427 Participants Participants received pembrolizumab 400 mg IV every 6 weeks for 18 cycles (each cycle length = 6 weeks, approximately 2 years) plus chemotherapy with FP (cisplatin 80 mg/m\^2 IV Q3W for up to 6 administrations \[up to \~18 weeks\] and 5-FU 4000 mg/m\^2 IV Q3W for up to 35 administrations \[up to \~2 years\]) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2 Q3W for up 6 administrations \[up to \~18 weeks\]) or in combination with mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2 and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] IV Q2W for up to 52 administrations \[approximately 2 years\]).
Part 2 (Main Study): Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR in All Participants	—	8.1 Months Interval 6.9 to 9.7	6.8 Months Interval 5.8 to 8.3

SECONDARY outcome

Timeframe: Up to 42 months

Population: Randomized participants in Part 2 who were analyzed according to the group assigned at randomization. Participants with PD-L1 CPS ≥10 only. Per protocol participants in Part 1 were excluded from analysis.

OS is defined as the time from randomization to death due to any cause. OS in Part 2 for randomized participants with PD-L1 CPS ≥10 are presented based on the Kaplan-Meier method for censored data.

Outcome measures

Outcome measures
Measure	Part 1: Pembrolizumab + Lenvatinib + Chemotherapy In the Induction phase, participants received pembrolizumab 400 mg IV Q6W for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg PO QD plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations at the investigator's discretion (approximately 12 weeks). In the Consolidation phase, participants received pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks).	Part 2: Pembrolizumab + Lenvatinib + Chemotherapy n=277 Participants In the Induction phase, participants received pembrolizumab 400 mg IV Q6W for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg PO QD plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 4000 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations or mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2, and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] once every 2 weeks \[Q2W\] for 6 administrations at the investigator's discretion (approximately 12 weeks). In the Consolidation phase, participants received pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks).	Part 2: Pembrolizumab + Chemotherapy n=277 Participants Participants received pembrolizumab 400 mg IV every 6 weeks for 18 cycles (each cycle length = 6 weeks, approximately 2 years) plus chemotherapy with FP (cisplatin 80 mg/m\^2 IV Q3W for up to 6 administrations \[up to \~18 weeks\] and 5-FU 4000 mg/m\^2 IV Q3W for up to 35 administrations \[up to \~2 years\]) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2 Q3W for up 6 administrations \[up to \~18 weeks\]) or in combination with mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2 and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] IV Q2W for up to 52 administrations \[approximately 2 years\]).
Part 2 (Main Study): OS in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10	—	18.0 Months Interval 16.4 to 20.4	15.8 Months Interval 13.1 to 17.4

SECONDARY outcome

Timeframe: Up to 42 months

PFS is defined as the time from randomization to the first documented PD per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. RECIST 1.1 has been adjusted to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. PFS in Part 2 for randomized participants with PD-L1 CPS ≥10 are presented based on the Kaplan-Meier method for censored data.

Outcome measures

Outcome measures
Measure	Part 1: Pembrolizumab + Lenvatinib + Chemotherapy In the Induction phase, participants received pembrolizumab 400 mg IV Q6W for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg PO QD plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations at the investigator's discretion (approximately 12 weeks). In the Consolidation phase, participants received pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks).	Part 2: Pembrolizumab + Lenvatinib + Chemotherapy n=277 Participants In the Induction phase, participants received pembrolizumab 400 mg IV Q6W for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg PO QD plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 4000 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations or mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2, and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] once every 2 weeks \[Q2W\] for 6 administrations at the investigator's discretion (approximately 12 weeks). In the Consolidation phase, participants received pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks).	Part 2: Pembrolizumab + Chemotherapy n=277 Participants Participants received pembrolizumab 400 mg IV every 6 weeks for 18 cycles (each cycle length = 6 weeks, approximately 2 years) plus chemotherapy with FP (cisplatin 80 mg/m\^2 IV Q3W for up to 6 administrations \[up to \~18 weeks\] and 5-FU 4000 mg/m\^2 IV Q3W for up to 35 administrations \[up to \~2 years\]) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2 Q3W for up 6 administrations \[up to \~18 weeks\]) or in combination with mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2 and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] IV Q2W for up to 52 administrations \[approximately 2 years\]).
Part 2 (Main Study): PFS Per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS ≥10	—	8.1 Months Interval 6.9 to 9.5	6.9 Months Interval 6.3 to 7.2

SECONDARY outcome

Timeframe: Up to 42 months

ORR is defined as the percentage of participants with CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), per RECIST 1.1 adjusted to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, as assessed by BICR. ORR in Part 2 for randomized participants with PD-L1 CPS ≥10 are presented.

Outcome measures

Outcome measures
Measure	Part 1: Pembrolizumab + Lenvatinib + Chemotherapy In the Induction phase, participants received pembrolizumab 400 mg IV Q6W for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg PO QD plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations at the investigator's discretion (approximately 12 weeks). In the Consolidation phase, participants received pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks).	Part 2: Pembrolizumab + Lenvatinib + Chemotherapy n=277 Participants In the Induction phase, participants received pembrolizumab 400 mg IV Q6W for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg PO QD plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 4000 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations or mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2, and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] once every 2 weeks \[Q2W\] for 6 administrations at the investigator's discretion (approximately 12 weeks). In the Consolidation phase, participants received pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks).	Part 2: Pembrolizumab + Chemotherapy n=277 Participants Participants received pembrolizumab 400 mg IV every 6 weeks for 18 cycles (each cycle length = 6 weeks, approximately 2 years) plus chemotherapy with FP (cisplatin 80 mg/m\^2 IV Q3W for up to 6 administrations \[up to \~18 weeks\] and 5-FU 4000 mg/m\^2 IV Q3W for up to 35 administrations \[up to \~2 years\]) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2 Q3W for up 6 administrations \[up to \~18 weeks\]) or in combination with mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2 and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] IV Q2W for up to 52 administrations \[approximately 2 years\]).
Part 2 (Main Study): ORR Per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS ≥10	—	62.5 Percentage of participants Interval 56.5 to 68.2	57.0 Percentage of participants Interval 51.0 to 62.9

SECONDARY outcome

Timeframe: Up to 42 months

For participants who demonstrate a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), per RECIST 1.1 by BICR, DOR is defined as the time from first documented evidence of CR or PR until PD or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. RECIST 1.1 has been adjusted to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. DOR in Part 2 for randomized participants with PD-L1 CPS ≥10 are presented based on the Kaplan-Meier method for censored data.

Outcome measures

Outcome measures
Measure	Part 1: Pembrolizumab + Lenvatinib + Chemotherapy In the Induction phase, participants received pembrolizumab 400 mg IV Q6W for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg PO QD plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations at the investigator's discretion (approximately 12 weeks). In the Consolidation phase, participants received pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks).	Part 2: Pembrolizumab + Lenvatinib + Chemotherapy n=277 Participants In the Induction phase, participants received pembrolizumab 400 mg IV Q6W for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg PO QD plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 4000 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations or mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2, and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] once every 2 weeks \[Q2W\] for 6 administrations at the investigator's discretion (approximately 12 weeks). In the Consolidation phase, participants received pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks).	Part 2: Pembrolizumab + Chemotherapy n=277 Participants Participants received pembrolizumab 400 mg IV every 6 weeks for 18 cycles (each cycle length = 6 weeks, approximately 2 years) plus chemotherapy with FP (cisplatin 80 mg/m\^2 IV Q3W for up to 6 administrations \[up to \~18 weeks\] and 5-FU 4000 mg/m\^2 IV Q3W for up to 35 administrations \[up to \~2 years\]) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2 Q3W for up 6 administrations \[up to \~18 weeks\]) or in combination with mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2 and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] IV Q2W for up to 52 administrations \[approximately 2 years\]).
Part 2 (Main Study): DOR Per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS ≥10	—	9.7 Months Interval 6.9 to 13.6	6.9 Months Interval 5.7 to 8.3

SECONDARY outcome

Timeframe: Up to 43 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 22 months

Outcome measures

Outcome data not reported

Adverse Events

Part 1 Pembrolizumab + Lenvatinib + Chemotherapy First Course

Serious events: 7 serious events

Other events: 13 other events

Deaths: 12 deaths

Part 2 Pembrolizumab + Lenvatinib + Chemotherapy First Course

Serious events: 224 serious events

Other events: 412 other events

Deaths: 236 deaths

Part 2 Pembrolizumab + Chemotherapy First Course

Serious events: 201 serious events

Other events: 417 other events

Deaths: 246 deaths

Part 2 Pembrolizumab + Lenvatinib + Chemotherapy Second Course

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 2 Pembrolizumab + Chemotherapy Second Course

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part 1 Pembrolizumab + Lenvatinib + Chemotherapy First Course n=13 participants at risk In the Induction phase, participants received pembrolizumab 400 mg intravenously (IV) every 6 weeks (Q6W) for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg orally (PO) once daily (QD) plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations at the investigator's discretion (approximately 12 weeks). In the Consolidation phase, participants received pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks).	Part 2 Pembrolizumab + Lenvatinib + Chemotherapy First Course n=421 participants at risk In the Induction phase, participants received pembrolizumab 400 mg IV Q6W for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg PO QD plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 4000 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations or mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2, and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] once every 2 weeks \[Q2W\] for 6 administrations at the investigator's discretion (approximately 12 weeks). In the Consolidation phase, participants received pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks).	Part 2 Pembrolizumab + Chemotherapy First Course n=426 participants at risk Participants received pembrolizumab 400 mg IV every 6 weeks for 18 cycles (each cycle length = 6 weeks, approximately 2 years) plus chemotherapy with FP (cisplatin 80 mg/m\^2 IV Q3W for up to 6 administrations \[up to \~18 weeks\] and 5-FU 4000 mg/m\^2 IV Q3W for up to 35 administrations \[up to \~2 years\]) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2 Q3W for up 6 administrations \[up to \~18 weeks\]) or in combination with mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2 and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] IV Q2W for up to 52 administrations \[approximately 2 years\]).	Part 2 Pembrolizumab + Lenvatinib + Chemotherapy Second Course n=1 participants at risk Participants initially randomized to Part 2 Pembrolizumab + Lenvatinib + Chemotherapy first course, who stopped intervention with stable disease (SD) or better were eligible for treatment with a second course of Pembrolizumab for up to an additional 9 cycles (1 year) at the investigator's discretion.	Part 2 Pembrolizumab + Chemotherapy Second Course Participants initially randomized to Part 2 Pembrolizumab + Chemotherapy first course, who stopped intervention with SD or better were eligible for treatment with a second course of Pembrolizumab for up to an additional 9 cycles (1 year) at the investigator's discretion.
Blood and lymphatic system disorders Anaemia	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.95% 4/421 • Number of events 4 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 5/426 • Number of events 6 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Blood and lymphatic system disorders Bicytopenia	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	2.4% 10/421 • Number of events 10 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	2.3% 10/426 • Number of events 10 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Blood and lymphatic system disorders Haematotoxicity	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Cardiac disorders Acute myocardial infarction	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Cardiac disorders Atrial fibrillation	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.71% 3/421 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.47% 2/426 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Cardiac disorders Atrioventricular block complete	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Cardiac disorders Cardiac arrest	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Cardiac disorders Cardiac failure	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.48% 2/421 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Cardiac disorders Cardiac tamponade	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Cardiac disorders Coronary artery disease	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Cardiac disorders Myocardial infarction	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Cardiac disorders Myocarditis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Cardiac disorders Pericardial effusion	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Cardiac disorders Ventricular tachycardia	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Congenital, familial and genetic disorders Tracheo-oesophageal fistula	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.95% 4/421 • Number of events 4 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Endocrine disorders Adrenal insufficiency	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	2.1% 9/421 • Number of events 9 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.70% 3/426 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Endocrine disorders Hypopituitarism	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.48% 2/421 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Abdominal pain	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.48% 2/421 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.70% 3/426 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Abdominal strangulated hernia	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Acute abdomen	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Anal fistula	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Ascites	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Colitis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.71% 3/421 • Number of events 4 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Constipation	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Diarrhoea	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.9% 8/421 • Number of events 9 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Dysphagia	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	6.2% 26/421 • Number of events 28 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	4.7% 20/426 • Number of events 20 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Enteritis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Gastritis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Haematemesis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.47% 2/426 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Ileus	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.48% 2/421 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Immune-mediated enterocolitis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Immune-mediated pancreatitis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Inguinal hernia	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.48% 2/421 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.48% 2/421 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Intestinal perforation	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Intra-abdominal fluid collection	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Large intestine perforation	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Melaena	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Nausea	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 5/421 • Number of events 5 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.94% 4/426 • Number of events 4 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Oesophageal fistula	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.95% 4/421 • Number of events 4 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.47% 2/426 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Oesophageal haemorrhage	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Oesophageal obstruction	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 5/421 • Number of events 5 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.70% 3/426 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Oesophageal perforation	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Oesophageal stenosis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 5/421 • Number of events 5 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Oesophagitis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.48% 2/421 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Pancreatitis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Pancreatitis chronic	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Retroperitoneal haemorrhage	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Stomatitis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.95% 4/421 • Number of events 4 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.48% 2/421 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.70% 3/426 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Vomiting	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.48% 2/421 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.47% 2/426 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
General disorders Catheter site swelling	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
General disorders Chest pain	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
General disorders Death	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.71% 3/421 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.6% 7/426 • Number of events 7 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
General disorders Device related thrombosis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
General disorders Fatigue	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.48% 2/421 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.70% 3/426 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
General disorders General physical health deterioration	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.71% 3/421 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
General disorders Influenza like illness	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
General disorders Localised oedema	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
General disorders Malaise	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.48% 2/421 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.70% 3/426 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
General disorders Mucosal inflammation	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
General disorders Oedema	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
General disorders Pyrexia	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 5/421 • Number of events 5 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	2.1% 9/426 • Number of events 10 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
General disorders Sudden death	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.48% 2/421 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Hepatobiliary disorders Bile duct stone	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Hepatobiliary disorders Cholangitis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Hepatobiliary disorders Cholecystitis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.48% 2/421 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Hepatobiliary disorders Cholestasis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Hepatobiliary disorders Hepatitis cholestatic	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Hepatobiliary disorders Immune-mediated hepatitis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.71% 3/421 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Hepatobiliary disorders Jaundice cholestatic	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Hepatobiliary disorders Liver disorder	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.48% 2/421 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Immune system disorders Anaphylactic reaction	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.48% 2/421 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Immune system disorders Drug hypersensitivity	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.47% 2/426 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Immune system disorders Hypersensitivity	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Abdominal infection	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.48% 2/421 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Anal abscess	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Appendicitis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.95% 4/421 • Number of events 4 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.70% 3/426 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Appendicitis perforated	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Bacteraemia	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Bacterial infection	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Biliary tract infection	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Bronchitis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations COVID-19	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.95% 4/421 • Number of events 4 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 5/426 • Number of events 5 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations COVID-19 pneumonia	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.70% 3/426 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Carbuncle	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Catheter site infection	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.48% 2/421 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Cellulitis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Clostridium difficile colitis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Cystitis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.47% 2/426 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Cytomegalovirus infection	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Device related infection	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Diarrhoea infectious	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.71% 3/421 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Diverticulitis intestinal perforated	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Endocarditis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Enterocolitis infectious	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Fungaemia	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.48% 2/421 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Gastroenteritis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations H1N1 influenza	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Infection	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.47% 2/426 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Infective spondylitis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Influenza	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Intervertebral discitis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Lower respiratory tract infection	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Lung abscess	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.48% 2/421 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Meningitis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Neutropenic sepsis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Oesophageal candidiasis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Peritonitis bacterial	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Pneumonia	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	11.9% 50/421 • Number of events 54 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	8.5% 36/426 • Number of events 41 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Pneumonia aspiration	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.7% 7/421 • Number of events 8 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.47% 2/426 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Pneumonia bacterial	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.95% 4/421 • Number of events 4 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.47% 2/426 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Pneumonia influenzal	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Pneumonia mycoplasmal	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Post procedural sepsis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Pulmonary sepsis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Respiratory tract infection	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Sepsis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.48% 2/421 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.6% 7/426 • Number of events 7 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Septic shock	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 5/421 • Number of events 5 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Sinusitis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Stoma site infection	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Streptococcal bacteraemia	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Urinary tract infection	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Urosepsis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Viral infection	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Wound infection	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.48% 2/421 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Injury, poisoning and procedural complications Foreign body	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Injury, poisoning and procedural complications Gastrostomy failure	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Injury, poisoning and procedural complications Gastrostomy tube site complication	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.47% 2/426 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.94% 4/426 • Number of events 4 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Injury, poisoning and procedural complications Multiple fractures	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Injury, poisoning and procedural complications Procedural pneumothorax	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.48% 2/421 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Injury, poisoning and procedural complications Skull fractured base	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Injury, poisoning and procedural complications Stoma site discharge	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Injury, poisoning and procedural complications Stoma site pain	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Investigations Alanine aminotransferase increased	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.94% 4/426 • Number of events 4 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Investigations Aspartate aminotransferase increased	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.47% 2/426 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Investigations Blood bilirubin increased	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.47% 2/426 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Investigations Blood creatinine increased	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.48% 2/421 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Investigations Creatinine renal clearance decreased	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Investigations Lipase increased	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Investigations Lymphocyte count decreased	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Investigations Neutrophil count decreased	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	2.4% 10/421 • Number of events 10 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.9% 8/426 • Number of events 9 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Investigations Platelet count decreased	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.4% 6/421 • Number of events 6 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.94% 4/426 • Number of events 5 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Investigations Troponin increased	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Investigations Weight decreased	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.48% 2/421 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.47% 2/426 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Investigations White blood cell count decreased	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.71% 3/421 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.47% 2/426 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Metabolism and nutrition disorders Cachexia	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.48% 2/421 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.7% 7/421 • Number of events 8 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.6% 7/426 • Number of events 9 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Metabolism and nutrition disorders Dehydration	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.48% 2/421 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Metabolism and nutrition disorders Fulminant type 1 diabetes mellitus	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Metabolism and nutrition disorders Hyperammonaemia	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.48% 2/421 • Number of events 4 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.71% 3/421 • Number of events 4 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Metabolism and nutrition disorders Hyponatraemia	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Metabolism and nutrition disorders Hypophagia	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.71% 3/421 • Number of events 4 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Metabolism and nutrition disorders Malnutrition	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.70% 3/426 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Musculoskeletal and connective tissue disorders Crystal arthropathy	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Musculoskeletal and connective tissue disorders Fistula	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.47% 2/426 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour fistulisation	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 5/421 • Number of events 5 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour inflammation	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Nervous system disorders Brain oedema	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Nervous system disorders Cerebral infarction	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.71% 3/421 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Nervous system disorders Cerebrovascular accident	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Nervous system disorders Dizziness	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.47% 2/426 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Nervous system disorders Encephalopathy	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.48% 2/421 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Nervous system disorders Epilepsy	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Nervous system disorders Generalised onset non-motor seizure	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Nervous system disorders Hepatic encephalopathy	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Nervous system disorders Intracranial aneurysm	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Nervous system disorders Ischaemic stroke	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Nervous system disorders Lumbar radiculopathy	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Nervous system disorders Monoparesis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Nervous system disorders Neuralgia	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Nervous system disorders Neuralgic amyotrophy	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Nervous system disorders Polyradiculoneuropathy	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Nervous system disorders Seizure	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.47% 2/426 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Nervous system disorders Sensory disturbance	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Nervous system disorders Syncope	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Nervous system disorders Toxic encephalopathy	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Product Issues Device dislocation	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.48% 2/421 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Product Issues Device occlusion	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Psychiatric disorders Completed suicide	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.47% 2/426 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Psychiatric disorders Delirium	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Renal and urinary disorders Acute kidney injury	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.4% 6/421 • Number of events 6 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.94% 4/426 • Number of events 4 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Renal and urinary disorders Azotaemia	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Renal and urinary disorders Cystitis noninfective	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Renal and urinary disorders Proteinuria	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Renal and urinary disorders Renal failure	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.47% 2/426 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Bronchial fistula	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Hydrothorax	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Immune-mediated lung disease	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.47% 2/426 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.70% 3/426 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Laryngeal oedema	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	3.6% 15/421 • Number of events 15 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	5.2% 22/426 • Number of events 22 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.48% 2/421 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.95% 4/421 • Number of events 4 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.47% 2/426 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Pulmonary veno-occlusive disease	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.48% 2/421 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.47% 2/426 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Sinus perforation	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Skin and subcutaneous tissue disorders Lichenoid keratosis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Skin and subcutaneous tissue disorders Rash	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Skin and subcutaneous tissue disorders Toxic epidermal necrolysis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Vascular disorders Aortic dissection	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Vascular disorders Deep vein thrombosis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Vascular disorders Embolism	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.47% 2/426 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Vascular disorders Giant cell arteritis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Vascular disorders Hypertension	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.71% 3/421 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Vascular disorders Hypertensive crisis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Vascular disorders Hypotension	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Vascular disorders Hypovolaemic shock	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Vascular disorders Obstructive shock	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Vascular disorders Orthostatic hypotension	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Vascular disorders Peripheral vein thrombosis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.48% 2/421 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Vascular disorders Phlebitis deep	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.

Other adverse events

Other adverse events
Measure	Part 1 Pembrolizumab + Lenvatinib + Chemotherapy First Course n=13 participants at risk In the Induction phase, participants received pembrolizumab 400 mg intravenously (IV) every 6 weeks (Q6W) for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg orally (PO) once daily (QD) plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations at the investigator's discretion (approximately 12 weeks). In the Consolidation phase, participants received pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks).	Part 2 Pembrolizumab + Lenvatinib + Chemotherapy First Course n=421 participants at risk In the Induction phase, participants received pembrolizumab 400 mg IV Q6W for 2 cycles (each cycle length = 6 weeks) plus Lenvatinib 8 mg PO QD plus chemotherapy with FP (cisplatin 80 mg/m\^2 and 5-FU 4000 mg/m\^2) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2) IV every 3 weeks for 4 administrations or mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2, and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] once every 2 weeks \[Q2W\] for 6 administrations at the investigator's discretion (approximately 12 weeks). In the Consolidation phase, participants received pembrolizumab 400 mg IV Q6W for 16 cycles (each cycle length = 6 weeks) and Lenvatinib 20 mg PO until progressive disease or discontinuation (approximately 96 weeks).	Part 2 Pembrolizumab + Chemotherapy First Course n=426 participants at risk Participants received pembrolizumab 400 mg IV every 6 weeks for 18 cycles (each cycle length = 6 weeks, approximately 2 years) plus chemotherapy with FP (cisplatin 80 mg/m\^2 IV Q3W for up to 6 administrations \[up to \~18 weeks\] and 5-FU 4000 mg/m\^2 IV Q3W for up to 35 administrations \[up to \~2 years\]) or TP (paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2 Q3W for up 6 administrations \[up to \~18 weeks\]) or in combination with mFOLFOX6 (oxaliplatin 85 mg/m\^2, 5-FU 400 mg/m\^2 followed by 2400 mg/m\^2 and leucovorin 400 mg/m\^2 \[or levoleucovorin 200 mg/m\^2\] IV Q2W for up to 52 administrations \[approximately 2 years\]).	Part 2 Pembrolizumab + Lenvatinib + Chemotherapy Second Course n=1 participants at risk Participants initially randomized to Part 2 Pembrolizumab + Lenvatinib + Chemotherapy first course, who stopped intervention with stable disease (SD) or better were eligible for treatment with a second course of Pembrolizumab for up to an additional 9 cycles (1 year) at the investigator's discretion.	Part 2 Pembrolizumab + Chemotherapy Second Course Participants initially randomized to Part 2 Pembrolizumab + Chemotherapy first course, who stopped intervention with SD or better were eligible for treatment with a second course of Pembrolizumab for up to an additional 9 cycles (1 year) at the investigator's discretion.
Endocrine disorders Hyperthyroidism	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	8.1% 34/421 • Number of events 37 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	3.3% 14/426 • Number of events 15 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Blood and lymphatic system disorders Anaemia	53.8% 7/13 • Number of events 11 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	37.5% 158/421 • Number of events 285 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	41.8% 178/426 • Number of events 281 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Cardiac disorders Tachycardia	7.7% 1/13 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.71% 3/421 • Number of events 4 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.47% 2/426 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Endocrine disorders Adrenal insufficiency	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	2.6% 11/421 • Number of events 11 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.4% 6/426 • Number of events 6 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Endocrine disorders Hypothyroidism	53.8% 7/13 • Number of events 8 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	33.5% 141/421 • Number of events 152 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	11.3% 48/426 • Number of events 51 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Eye disorders Corneal disorder	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Abdominal discomfort	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.70% 3/426 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Abdominal pain	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	6.9% 29/421 • Number of events 32 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	6.1% 26/426 • Number of events 31 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Abdominal pain upper	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	6.9% 29/421 • Number of events 34 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	3.1% 13/426 • Number of events 14 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Colitis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.71% 3/421 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	100.0% 1/1 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Constipation	15.4% 2/13 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	29.7% 125/421 • Number of events 158 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	29.3% 125/426 • Number of events 144 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Diarrhoea	61.5% 8/13 • Number of events 13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	38.2% 161/421 • Number of events 279 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	22.3% 95/426 • Number of events 141 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Dyspepsia	23.1% 3/13 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	4.5% 19/421 • Number of events 20 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	2.6% 11/426 • Number of events 11 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Dysphagia	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	9.0% 38/421 • Number of events 42 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	7.0% 30/426 • Number of events 35 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	5.5% 23/421 • Number of events 27 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	4.5% 19/426 • Number of events 22 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Mouth ulceration	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.7% 7/421 • Number of events 10 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 5/426 • Number of events 5 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Nausea	38.5% 5/13 • Number of events 10 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	44.9% 189/421 • Number of events 280 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	45.3% 193/426 • Number of events 320 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Stomatitis	38.5% 5/13 • Number of events 6 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	30.6% 129/421 • Number of events 174 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	16.4% 70/426 • Number of events 82 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Gastrointestinal disorders Vomiting	15.4% 2/13 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	18.1% 76/421 • Number of events 107 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	16.4% 70/426 • Number of events 101 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
General disorders Chest pain	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	3.8% 16/421 • Number of events 17 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	2.1% 9/426 • Number of events 9 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
General disorders Fatigue	46.2% 6/13 • Number of events 8 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	31.1% 131/421 • Number of events 201 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	27.9% 119/426 • Number of events 154 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
General disorders Malaise	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	14.3% 60/421 • Number of events 67 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	8.5% 36/426 • Number of events 45 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
General disorders Mucosal inflammation	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	7.6% 32/421 • Number of events 38 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	7.0% 30/426 • Number of events 44 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
General disorders Oedema peripheral	15.4% 2/13 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	4.0% 17/421 • Number of events 18 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	5.2% 22/426 • Number of events 27 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
General disorders Pyrexia	23.1% 3/13 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	13.1% 55/421 • Number of events 79 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	16.7% 71/426 • Number of events 108 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
General disorders Xerosis	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.71% 3/421 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Bronchitis	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	2.9% 12/421 • Number of events 14 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.2% 5/426 • Number of events 5 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations COVID-19	23.1% 3/13 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	6.9% 29/421 • Number of events 30 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	7.5% 32/426 • Number of events 32 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Device related bacteraemia	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Lung abscess	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Pneumonia	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	8.8% 37/421 • Number of events 39 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	4.5% 19/426 • Number of events 21 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Respiratory tract infection	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.71% 3/421 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.47% 2/426 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Stoma site infection	7.7% 1/13 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.71% 3/421 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Infections and infestations Upper respiratory tract infection	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	6.2% 26/421 • Number of events 30 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	4.2% 18/426 • Number of events 18 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Injury, poisoning and procedural complications Compression fracture	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Injury, poisoning and procedural complications Stoma site pain	15.4% 2/13 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.48% 2/421 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.47% 2/426 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Investigations Alanine aminotransferase increased	30.8% 4/13 • Number of events 7 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	16.2% 68/421 • Number of events 113 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	15.7% 67/426 • Number of events 97 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Investigations Amylase increased	23.1% 3/13 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	13.1% 55/421 • Number of events 85 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	17.6% 75/426 • Number of events 102 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Investigations Aspartate aminotransferase increased	30.8% 4/13 • Number of events 4 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	17.6% 74/421 • Number of events 123 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	18.5% 79/426 • Number of events 119 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Investigations Blood alkaline phosphatase increased	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	5.2% 22/421 • Number of events 27 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	8.0% 34/426 • Number of events 46 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Investigations Blood bilirubin increased	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	5.7% 24/421 • Number of events 35 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	5.4% 23/426 • Number of events 40 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Investigations Blood creatinine increased	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	8.3% 35/421 • Number of events 66 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	7.7% 33/426 • Number of events 51 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Investigations Blood magnesium decreased	7.7% 1/13 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.9% 8/421 • Number of events 16 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.94% 4/426 • Number of events 5 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Investigations Blood thyroid stimulating hormone increased	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	5.7% 24/421 • Number of events 29 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	2.3% 10/426 • Number of events 10 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Investigations Electrocardiogram QT prolonged	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.4% 6/421 • Number of events 14 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Investigations Lipase increased	15.4% 2/13 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	13.3% 56/421 • Number of events 80 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	15.7% 67/426 • Number of events 78 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Investigations Lymphocyte count decreased	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	7.4% 31/421 • Number of events 68 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	6.1% 26/426 • Number of events 64 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Investigations Neutrophil count decreased	61.5% 8/13 • Number of events 13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	54.2% 228/421 • Number of events 493 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	61.3% 261/426 • Number of events 612 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Investigations Platelet count decreased	23.1% 3/13 • Number of events 5 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	33.7% 142/421 • Number of events 277 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	37.3% 159/426 • Number of events 283 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Investigations SARS-CoV-2 test positive	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.71% 3/421 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Investigations Weight decreased	23.1% 3/13 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	24.0% 101/421 • Number of events 130 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	17.1% 73/426 • Number of events 88 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Investigations White blood cell count decreased	23.1% 3/13 • Number of events 7 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	28.0% 118/421 • Number of events 303 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	30.3% 129/426 • Number of events 339 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Metabolism and nutrition disorders Decreased appetite	38.5% 5/13 • Number of events 11 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	32.5% 137/421 • Number of events 196 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	27.0% 115/426 • Number of events 147 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Metabolism and nutrition disorders Hyperglycaemia	15.4% 2/13 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	6.7% 28/421 • Number of events 52 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	7.5% 32/426 • Number of events 48 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Metabolism and nutrition disorders Hyperkalaemia	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	4.3% 18/421 • Number of events 29 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	4.2% 18/426 • Number of events 20 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Metabolism and nutrition disorders Hypoalbuminaemia	23.1% 3/13 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	17.1% 72/421 • Number of events 164 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	13.4% 57/426 • Number of events 101 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Metabolism and nutrition disorders Hypocalcaemia	15.4% 2/13 • Number of events 4 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	7.6% 32/421 • Number of events 48 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	3.5% 15/426 • Number of events 22 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Metabolism and nutrition disorders Hypoglycaemia	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.4% 6/421 • Number of events 11 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.70% 3/426 • Number of events 5 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Metabolism and nutrition disorders Hypokalaemia	30.8% 4/13 • Number of events 6 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	15.9% 67/421 • Number of events 114 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.3% 44/426 • Number of events 79 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Metabolism and nutrition disorders Hypomagnesaemia	7.7% 1/13 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	8.6% 36/421 • Number of events 66 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	5.4% 23/426 • Number of events 38 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Metabolism and nutrition disorders Hyponatraemia	46.2% 6/13 • Number of events 11 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	15.7% 66/421 • Number of events 103 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.8% 46/426 • Number of events 79 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	5.2% 22/421 • Number of events 29 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	4.2% 18/426 • Number of events 25 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Metabolism and nutrition disorders Hypoproteinaemia	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.4% 6/421 • Number of events 8 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	2.1% 9/426 • Number of events 11 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Musculoskeletal and connective tissue disorders Arthralgia	15.4% 2/13 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	13.1% 55/421 • Number of events 74 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	3.8% 16/426 • Number of events 18 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	6.4% 27/421 • Number of events 30 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	4.0% 17/426 • Number of events 17 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.4% 6/421 • Number of events 7 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.71% 3/421 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.9% 8/426 • Number of events 9 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Musculoskeletal and connective tissue disorders Myalgia	15.4% 2/13 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	5.9% 25/421 • Number of events 27 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	2.6% 11/426 • Number of events 15 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Musculoskeletal and connective tissue disorders Soft tissue swelling	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Nervous system disorders Cognitive disorder	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.24% 1/421 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Nervous system disorders Dizziness	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	4.0% 17/421 • Number of events 18 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	6.8% 29/426 • Number of events 39 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Nervous system disorders Dysgeusia	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	5.2% 22/421 • Number of events 26 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	5.2% 22/426 • Number of events 25 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Nervous system disorders Headache	15.4% 2/13 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	7.4% 31/421 • Number of events 36 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	4.5% 19/426 • Number of events 21 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Nervous system disorders Hypoaesthesia	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	2.6% 11/421 • Number of events 13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	2.6% 11/426 • Number of events 11 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Nervous system disorders Neuropathy peripheral	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.0% 42/421 • Number of events 62 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	17.8% 76/426 • Number of events 105 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Nervous system disorders Paraesthesia	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	5.0% 21/421 • Number of events 25 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	6.6% 28/426 • Number of events 36 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	9.0% 38/421 • Number of events 51 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	13.8% 59/426 • Number of events 79 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Nervous system disorders Transient ischaemic attack	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Psychiatric disorders Agitation	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.23% 1/426 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Psychiatric disorders Insomnia	23.1% 3/13 • Number of events 4 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.7% 45/421 • Number of events 46 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	7.5% 32/426 • Number of events 39 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Renal and urinary disorders Anuria	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Renal and urinary disorders Proteinuria	23.1% 3/13 • Number of events 5 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	22.3% 94/421 • Number of events 160 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	5.4% 23/426 • Number of events 36 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Cough	15.4% 2/13 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.5% 44/421 • Number of events 51 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.3% 44/426 • Number of events 50 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	5.2% 22/421 • Number of events 25 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	1.4% 6/426 • Number of events 8 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	4.0% 17/421 • Number of events 18 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	4.5% 19/426 • Number of events 20 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	7.4% 31/421 • Number of events 37 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	2.8% 12/426 • Number of events 12 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Haemoptysis	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	2.6% 11/421 • Number of events 13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.70% 3/426 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Hiccups	23.1% 3/13 • Number of events 3 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	7.1% 30/421 • Number of events 38 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	6.6% 28/426 • Number of events 35 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Nasal dryness	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.48% 2/421 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Pneumonitis	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	3.6% 15/421 • Number of events 15 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	4.7% 20/426 • Number of events 21 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	5.5% 23/421 • Number of events 25 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	3.1% 13/426 • Number of events 15 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/13 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	4.8% 20/421 • Number of events 20 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	6.3% 27/426 • Number of events 28 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Skin and subcutaneous tissue disorders Blister	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/421 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	30.8% 4/13 • Number of events 4 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	25.9% 109/421 • Number of events 129 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	5.6% 24/426 • Number of events 25 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Skin and subcutaneous tissue disorders Pruritus	15.4% 2/13 • Number of events 2 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.7% 45/421 • Number of events 50 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	10.1% 43/426 • Number of events 50 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Skin and subcutaneous tissue disorders Rash	30.8% 4/13 • Number of events 4 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	18.3% 77/421 • Number of events 87 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	13.8% 59/426 • Number of events 75 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Skin and subcutaneous tissue disorders Skin exfoliation	7.7% 1/13 • Number of events 1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.48% 2/421 • Number of events 4 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/426 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
Vascular disorders Hypertension	38.5% 5/13 • Number of events 9 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	38.0% 160/421 • Number of events 236 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	5.4% 23/426 • Number of events 29 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	0.00% 0/1 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.	— 0/0 • All-cause mortality: from randomization up to a maximum of 43 months. Adverse events: from first treatment up to a maximum of 43 months All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. As it was pre-specified that disease progression of cancer was not considered an AE unless related to study drug, the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.

Additional Information

Senior Vice President, Senior Vice PreGlobal Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors authorship requirements.
Publication restrictions are in place

Restriction type: OTHER