Trial Outcomes & Findings for Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-7902-015/E7080-G000-321/LEAP-015) (NCT NCT04662710)

Last Updated: 2026-04-28

Results Overview

A DLT was defined as a specific adverse event graded for toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Hematologic DLTs included 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. Nonhematologic DLTs included 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 if medical intervention was required or the abnormality led to hospitalization. The number of participants in Part 1 with DLTs is reported.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

895 participants

Primary outcome timeframe

Up to ~21 days

Results posted on

2026-04-28

Participant Flow

This study included 2 parts: Part 1 was an open-label, safety run-in to evaluate the safety and tolerability of treatment with pembrolizumab + lenvatinib + chemotherapy. Participants in Part 1 continued to receive study intervention and were followed in the posttreatment period as applicable. Part 2 (main study) evaluated safety and efficacy. Participants were randomized to receive either treatment with pembrolizumab + lenvatinib + chemotherapy, or chemotherapy only.

Participant milestones

Participant milestones
Measure	Part 2: Lenvatinib + Pembrolizumab + Chemotherapy Participants received lenvatinib administered orally (PO) every day (QD) in combination with pembrolizumab intravenously (IV) every 6 weeks (Q6W) plus chemotherapy with either capecitabine and oxaliplatin (CAPOX) or chemotherapy with 5-FU, leucovorin, and oxaliplatin (mFOLFOX6). Induction with lenvatinib 8 mg QD plus pembrolizumab plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).	Part 2: Chemotherapy Participants received chemotherapy with either CAPOX every 3 weeks (Q3W) or mFOLFOX6 every 2 weeks (Q2W).	Part 1 : Lenvatinib + Pembrolizumab + Chemotherapy Participants received lenvatinib administered orally (PO) every day (QD) in combination with pembrolizumab intravenously (IV) every 6 weeks (Q6W) plus chemotherapy with either capecitabine and oxaliplatin (CAPOX) or chemotherapy with 5-FU, leucovorin, and oxaliplatin (mFOLFOX6). Induction with lenvatinib 8 mg QD plus pembrolizumab plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).
Overall Study STARTED	443	437	15
Overall Study Treated	441	429	15
Overall Study Received Second Course of Pembrolizumab +/- Lenvatinib	3	0	1
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	443	437	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 2: Lenvatinib + Pembrolizumab + Chemotherapy Participants received lenvatinib administered orally (PO) every day (QD) in combination with pembrolizumab intravenously (IV) every 6 weeks (Q6W) plus chemotherapy with either capecitabine and oxaliplatin (CAPOX) or chemotherapy with 5-FU, leucovorin, and oxaliplatin (mFOLFOX6). Induction with lenvatinib 8 mg QD plus pembrolizumab plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).	Part 2: Chemotherapy Participants received chemotherapy with either CAPOX every 3 weeks (Q3W) or mFOLFOX6 every 2 weeks (Q2W).	Part 1 : Lenvatinib + Pembrolizumab + Chemotherapy Participants received lenvatinib administered orally (PO) every day (QD) in combination with pembrolizumab intravenously (IV) every 6 weeks (Q6W) plus chemotherapy with either capecitabine and oxaliplatin (CAPOX) or chemotherapy with 5-FU, leucovorin, and oxaliplatin (mFOLFOX6). Induction with lenvatinib 8 mg QD plus pembrolizumab plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).
Overall Study Ongoing	109	56	1
Overall Study Death	331	367	14
Overall Study Withdrawal by Subject	3	14	0

Baseline Characteristics

Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-7902-015/E7080-G000-321/LEAP-015)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: Lenvatinib +Pembrolizumab + Chemotherapy n=15 Participants Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab (plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).	Part 2: Lenvatinib + Pembrolizumab + Chemotherapy n=443 Participants Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab (plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).	Part 2: Chemotherapy n=437 Participants Participants received chemotherapy with either CAPOX Q3W or mFOLFOX6 Q2W.	Total n=895 Participants Total of all reporting groups
Age, Continuous	55.9 Years STANDARD_DEVIATION 59.7 • n=9 Participants	59.7 Years STANDARD_DEVIATION 12.5 • n=24 Participants	59.1 Years STANDARD_DEVIATION 12.0 • n=23 Participants	59.3 Years STANDARD_DEVIATION 12.3 • n=73 Participants
Sex: Female, Male Female	8 Participants n=9 Participants	151 Participants n=24 Participants	131 Participants n=23 Participants	290 Participants n=73 Participants
Sex: Female, Male Male	7 Participants n=9 Participants	292 Participants n=24 Participants	306 Participants n=23 Participants	605 Participants n=73 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=9 Participants	116 Participants n=24 Participants	115 Participants n=23 Participants	238 Participants n=73 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=9 Participants	319 Participants n=24 Participants	313 Participants n=23 Participants	640 Participants n=73 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	8 Participants n=24 Participants	9 Participants n=23 Participants	17 Participants n=73 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants	11 Participants n=24 Participants	15 Participants n=23 Participants	26 Participants n=73 Participants
Race (NIH/OMB) Asian	4 Participants n=9 Participants	164 Participants n=24 Participants	161 Participants n=23 Participants	329 Participants n=73 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants	0 Participants n=24 Participants	0 Participants n=23 Participants	0 Participants n=73 Participants
Race (NIH/OMB) Black or African American	0 Participants n=9 Participants	1 Participants n=24 Participants	1 Participants n=23 Participants	2 Participants n=73 Participants
Race (NIH/OMB) White	11 Participants n=9 Participants	235 Participants n=24 Participants	223 Participants n=23 Participants	469 Participants n=73 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants	30 Participants n=24 Participants	36 Participants n=23 Participants	66 Participants n=73 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	2 Participants n=24 Participants	1 Participants n=23 Participants	3 Participants n=73 Participants
Geographic Region of Enrolling Site East Asia	4 Participants n=9 Participants	161 Participants n=24 Participants	160 Participants n=23 Participants	325 Participants n=73 Participants
Geographic Region of Enrolling Site North America + Western Europe	5 Participants n=9 Participants	125 Participants n=24 Participants	122 Participants n=23 Participants	252 Participants n=73 Participants
Geographic Region of Enrolling Site Rest of the World	6 Participants n=9 Participants	157 Participants n=24 Participants	155 Participants n=23 Participants	318 Participants n=73 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG 0	11 Participants n=9 Participants	204 Participants n=24 Participants	204 Participants n=23 Participants	419 Participants n=73 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG 1	4 Participants n=9 Participants	239 Participants n=24 Participants	233 Participants n=23 Participants	476 Participants n=73 Participants
Intended Chemotherapy CAPOX	7 Participants n=9 Participants	232 Participants n=24 Participants	225 Participants n=23 Participants	464 Participants n=73 Participants
Intended Chemotherapy mFOLFOX6	8 Participants n=9 Participants	209 Participants n=24 Participants	204 Participants n=23 Participants	421 Participants n=73 Participants
Intended Chemotherapy Missing	0 Participants n=9 Participants	2 Participants n=24 Participants	8 Participants n=23 Participants	10 Participants n=73 Participants

PRIMARY outcome

Timeframe: Up to ~21 days

Population: All randomized participants who received at least 1 dose of study intervention. Per protocol, only participants in part 1 were included

Outcome measures

Outcome measures
Measure	Part 1 : Lenvatinib + Pembrolizumab + Chemotherapy n=15 Participants Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).	Part 2: Lenvatinib + Pembrolizumab + Chemotherapy Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab (plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).	Part 2: Chemotherapy Participants received chemotherapy with either CAPOX Q3W or mFOLFOX6 Q2W.
Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)	2 Participants	—	—

PRIMARY outcome

Timeframe: Up to ~44 months

Population: All randomized participants who received at least 1 dose of study intervention. Per protocol, only participants in part 1 were included

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

Outcome measures

Outcome measures
Measure	Part 1 : Lenvatinib + Pembrolizumab + Chemotherapy n=15 Participants Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).	Part 2: Lenvatinib + Pembrolizumab + Chemotherapy Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab (plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).	Part 2: Chemotherapy Participants received chemotherapy with either CAPOX Q3W or mFOLFOX6 Q2W.
Part 1: Number of Participants With Adverse Events (AEs)	15 Participants	—	—

PRIMARY outcome

Timeframe: Up to ~29 months

Population: All randomized participants who received at least 1 dose of study intervention. Per protocol, only participants in part 1 were included

Outcome measures

Outcome measures
Measure	Part 1 : Lenvatinib + Pembrolizumab + Chemotherapy n=15 Participants Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).	Part 2: Lenvatinib + Pembrolizumab + Chemotherapy Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab (plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).	Part 2: Chemotherapy Participants received chemotherapy with either CAPOX Q3W or mFOLFOX6 Q2W.
Part 1: Number of Participants Who Discontinued Study Treatment Due to an AE	5 Participants	—	—

PRIMARY outcome

Timeframe: Up to ~41 months

Population: All randomized participants, whether or not study intervention was administered, with PD-L1 CPS≥1 and who had available data for the outcome measure at the time of final analysis. Per protocol, participants in part 1 of the study were not included in the OS analysis.

OS is defined as the time from randomization to death due to any cause. OS is reported by treatment arm for PD-L1 CPS ≥1 participants in Part 2.

Outcome measures

Outcome measures
Measure	Part 1 : Lenvatinib + Pembrolizumab + Chemotherapy n=334 Participants Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).	Part 2: Lenvatinib + Pembrolizumab + Chemotherapy n=355 Participants Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab (plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).	Part 2: Chemotherapy Participants received chemotherapy with either CAPOX Q3W or mFOLFOX6 Q2W.
Part 2: Overall Survival (OS) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1	12.6 Months Interval 10.6 to 14.2	12.9 Months Interval 11.6 to 14.6	—

PRIMARY outcome

Timeframe: Up to ~41 months

Population: All randomized participants, whether or not study intervention was administered and who had available data for the outcome measure at the time of final analysis. Per protocol, participants in part 1 of the study were not included in the OS analysis.

OS is defined as the time from randomization to death due to any cause. OS is reported by treatment arm for all participants in Part 2.

Outcome measures

Outcome measures
Measure	Part 1 : Lenvatinib + Pembrolizumab + Chemotherapy n=443 Participants Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).	Part 2: Lenvatinib + Pembrolizumab + Chemotherapy n=437 Participants Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab (plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).	Part 2: Chemotherapy Participants received chemotherapy with either CAPOX Q3W or mFOLFOX6 Q2W.
Part 2: OS in All Participants	13.1 Months Interval 11.6 to 14.3	13.0 Months Interval 11.6 to 14.7	—

PRIMARY outcome

Timeframe: Up to ~29 months

Population: All randomized participants, whether or not study intervention was administered, with PD-L1 CPS ≥1 and who had available data for the outcome measure at the time of final analysis. Per protocol, participants in part 1 of the study were not included in the PFS analysis

PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 by BICR or death from any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, 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. PFS is reported by treatment arm for PD-L1 CPS ≥1 participants in Part 2.

Outcome measures

Outcome measures
Measure	Part 1 : Lenvatinib + Pembrolizumab + Chemotherapy n=333 Participants Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).	Part 2: Lenvatinib + Pembrolizumab + Chemotherapy n=355 Participants Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab (plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).	Part 2: Chemotherapy Participants received chemotherapy with either CAPOX Q3W or mFOLFOX6 Q2W.
Part 2: 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 Participants With PD-L1 CPS ≥1	7.3 Months Interval 6.8 to 8.3	6.9 Months Interval 5.8 to 7.2	—

PRIMARY outcome

Timeframe: Up to ~29 months

PFS is defined as the time from randomization to the first documented PD per RECIST 1.1 by BICR or death from any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, 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. PFS is reported by treatment arm for all participants in Part 2.

Outcome measures

Outcome measures
Measure	Part 1 : Lenvatinib + Pembrolizumab + Chemotherapy n=443 Participants Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).	Part 2: Lenvatinib + Pembrolizumab + Chemotherapy n=437 Participants Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab (plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).	Part 2: Chemotherapy Participants received chemotherapy with either CAPOX Q3W or mFOLFOX6 Q2W.
Part 2: PFS Per RECIST 1.1 as Assessed by BICR in All Participants	7.2 Months Interval 6.8 to 8.3	7.0 Months Interval 6.4 to 7.5	—

SECONDARY outcome

Timeframe: Up to ~29 months

Population: All randomized participants, whether or not study intervention was administered, with PD-L1 CPS ≥1 and who had available data for the outcome measure at the time of final analysis. Per protocol, participants in part 1 of the study were not included in the ORR analysis.

ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and assessed by BICR. ORR is reported by treatment arm for PD-L1 CPS ≥1 participants in Part 2.

Outcome measures

Outcome measures
Measure	Part 1 : Lenvatinib + Pembrolizumab + Chemotherapy n=333 Participants Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).	Part 2: Lenvatinib + Pembrolizumab + Chemotherapy n=355 Participants Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab (plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).	Part 2: Chemotherapy Participants received chemotherapy with either CAPOX Q3W or mFOLFOX6 Q2W.
Part 2: Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS ≥1	59.5 Percentage of Participants Interval 54.0 to 64.8	45.4 Percentage of Participants Interval 40.1 to 50.7	—

SECONDARY outcome

Timeframe: Up to ~29 months

ORR is defined as the percentage of participants in the analysis population who have a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and assessed by BICR. ORR is reported by treatment arm for all participants in Part 2.

Outcome measures

Outcome measures
Measure	Part 1 : Lenvatinib + Pembrolizumab + Chemotherapy n=443 Participants Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).	Part 2: Lenvatinib + Pembrolizumab + Chemotherapy n=437 Participants Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab (plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).	Part 2: Chemotherapy Participants received chemotherapy with either CAPOX Q3W or mFOLFOX6 Q2W.
Part 2: ORR Per RECIST 1.1 as Assessed by BICR in All Participants	58.0 Percentage of Participants Interval 53.3 to 62.7	43.9 Percentage of Participants Interval 39.2 to 48.7	—

SECONDARY outcome

Timeframe: Up to ~41 months

Population: All randomized participants who achieved CR or PR with PD-L1 CPS \> or =1 and who had available data for the outcome measure at the time of final analysis. Participants were analyzed in the treatment group to which they were randomized. Per protocol, participants in part 1 of the study were not included in the DOR analysis.

For participants who demonstrated confirmed CR or PR, DOR is defined as the time from the first CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) to subsequent PD or death due to any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, 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. DOR is reported by treatment arm for PD-L1 CPS ≥1 participants in Part 2.

Outcome measures

Outcome measures
Measure	Part 1 : Lenvatinib + Pembrolizumab + Chemotherapy n=198 Participants Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).	Part 2: Lenvatinib + Pembrolizumab + Chemotherapy n=161 Participants Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab (plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).	Part 2: Chemotherapy Participants received chemotherapy with either CAPOX Q3W or mFOLFOX6 Q2W.
Part 2: Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS ≥1	8.5 Months Interval 7.1 to 12.5	6.5 Months Interval 5.6 to 7.0	—

SECONDARY outcome

Timeframe: Up to ~41 months

Population: All randomized participants who achieved CR or PR and who had available data for the outcome measure at the time of final analysis. Participants were analyzed in the treatment group to which they were randomized. Per protocol, participants in part 1 of the study were not included in the DOR analysis.

Outcome measures

Outcome measures
Measure	Part 1 : Lenvatinib + Pembrolizumab + Chemotherapy n=255 Participants Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).	Part 2: Lenvatinib + Pembrolizumab + Chemotherapy n=192 Participants Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab (plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).	Part 2: Chemotherapy Participants received chemotherapy with either CAPOX Q3W or mFOLFOX6 Q2W.
Part 2: DOR Per RECIST 1.1 as Assessed by BICR in All Participants	8.6 Months Interval 7.3 to 12.4	6.7 Months Interval 5.6 to 7.7	—

SECONDARY outcome

Timeframe: Up to ~41 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to ~41 months

Outcome measures

Outcome data not reported

Adverse Events

Part 2: Lenvatinib + Pembrolizumab + Chemotherapy First Course

Serious events: 226 serious events

Other events: 435 other events

Deaths: 333 deaths

Chemotherapy First Course

Serious events: 137 serious events

Other events: 406 other events

Deaths: 374 deaths

Part 1: Lenvatinib + Pembrolizumab + Chemotherapy First Course

Serious events: 6 serious events

Other events: 14 other events

Deaths: 13 deaths

Part 1: Pembrolizumab +/-Lenvatinib Second Course

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Part 2: Pembrolizumab +/-Lenvatinib Second Course

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part 2: Lenvatinib + Pembrolizumab + Chemotherapy First Course n=441 participants at risk Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab (plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).	Chemotherapy First Course n=429 participants at risk Participants received chemotherapy with either CAPOX Q3W or mFOLFOX6 Q2W. A cycle is 6 weeks (42 days).	Part 1: Lenvatinib + Pembrolizumab + Chemotherapy First Course n=15 participants at risk Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).	Part 1: Pembrolizumab +/-Lenvatinib Second Course n=1 participants at risk Participants treated with pembrolizumab who completed 18 cycles of treatment with SD or better, or participants who attained an investigator-determined CR and received at least 4 cycles of pembrolizumab were eligible for retreatment with up to an additional 9 cycles of pembrolizumab if they experienced radiographic disease progression confirmed by BICR after stopping treatment in the initial treatment phase. Lenvatinib was administered per investigator's discretion	Part 2: Pembrolizumab +/-Lenvatinib Second Course n=3 participants at risk Participants treated with pembrolizumab who completed 18 cycles of treatment with SD or better, or participants who attained an investigator-determined CR and received at least 4 cycles of pembrolizumab were eligible for retreatment with up to an additional 9 cycles of pembrolizumab if they experience radiographic disease progression confirmed by BICR after stopping treatment in the initial treatment phase. Lenvatinib was administered per investigator's discretion
Blood and lymphatic system disorders Anaemia	0.68% 3/441 • Number of events 3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.70% 3/429 • Number of events 3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Blood and lymphatic system disorders Autoimmune haemolytic anaemia	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Blood and lymphatic system disorders Febrile neutropenia	1.1% 5/441 • Number of events 6 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.47% 2/429 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Cardiac disorders Acute myocardial infarction	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Cardiac disorders Angina pectoris	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Cardiac disorders Arteriospasm coronary	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Cardiac disorders Atrial fibrillation	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Cardiac disorders Atrial thrombosis	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Cardiac disorders Atrioventricular block complete	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Cardiac disorders Cardiac arrest	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Cardiac disorders Cardiac failure	1.1% 5/441 • Number of events 5 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.47% 2/429 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Cardiac disorders Cardiac failure congestive	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Cardiac disorders Cardiomyopathy	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Cardiac disorders Conduction disorder	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Cardiac disorders Coronary artery disease	0.45% 2/441 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Cardiac disorders Myocarditis	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Congenital, familial and genetic disorders Dihydropyrimidine dehydrogenase deficiency	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Endocrine disorders Adrenal insufficiency	0.91% 4/441 • Number of events 4 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Endocrine disorders Hyperthyroidism	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Endocrine disorders Hypophysitis	0.45% 2/441 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Endocrine disorders Hypothyroidism	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Endocrine disorders Immune-mediated hypothyroidism	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Eye disorders Cataract	0.23% 1/441 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Abdominal distension	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Abdominal pain	1.4% 6/441 • Number of events 6 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.47% 2/429 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Anal fistula	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Ascites	0.68% 3/441 • Number of events 3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.93% 4/429 • Number of events 4 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Colitis	0.91% 4/441 • Number of events 4 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Diarrhoea	2.9% 13/441 • Number of events 14 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.93% 4/429 • Number of events 4 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Dysphagia	1.4% 6/441 • Number of events 7 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.93% 4/429 • Number of events 4 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Enteritis	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Enterocolitis	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Gastric haemorrhage	1.1% 5/441 • Number of events 6 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Gastric perforation	1.6% 7/441 • Number of events 7 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Gastric ulcer	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Gastric ulcer perforation	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Gastritis	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Gastrointestinal disorder	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.91% 4/441 • Number of events 4 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	1.4% 6/429 • Number of events 8 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Gastrointestinal pain	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Gastrointestinal perforation	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Haematemesis	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Ileus	0.45% 2/441 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Ileus paralytic	0.45% 2/441 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Immune-mediated enterocolitis	0.45% 2/441 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Impaired gastric emptying	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Incarcerated inguinal hernia	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Inguinal hernia	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Intestinal ischaemia	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Intestinal obstruction	0.68% 3/441 • Number of events 3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	2.6% 11/429 • Number of events 12 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Intestinal perforation	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.47% 2/429 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Large intestine perforation	0.45% 2/441 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Melaena	0.23% 1/441 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Nausea	1.4% 6/441 • Number of events 6 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.47% 2/429 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Obstruction gastric	0.68% 3/441 • Number of events 6 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.93% 4/429 • Number of events 4 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Oesophageal food impaction	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Oesophageal stenosis	0.68% 3/441 • Number of events 3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Oesophagitis	0.45% 2/441 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Pancreatic pseudocyst	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Pancreatitis	0.45% 2/441 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Pancreatitis acute	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Pneumoperitoneum	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Small intestinal obstruction	0.45% 2/441 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Stomatitis	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	2.0% 9/441 • Number of events 9 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	2.1% 9/429 • Number of events 9 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Vomiting	2.3% 10/441 • Number of events 12 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	1.6% 7/429 • Number of events 7 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
General disorders Asthenia	0.91% 4/441 • Number of events 4 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
General disorders Cardiac death	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
General disorders Death	1.4% 6/441 • Number of events 6 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
General disorders Fatigue	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
General disorders General physical health deterioration	0.45% 2/441 • Number of events 3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
General disorders Malaise	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
General disorders Medical device pain	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
General disorders Mucosal inflammation	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
General disorders Pyrexia	0.91% 4/441 • Number of events 4 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.93% 4/429 • Number of events 4 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
General disorders Vascular device occlusion	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Hepatobiliary disorders Autoimmune hepatitis	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Hepatobiliary disorders Bile duct stone	0.45% 2/441 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Hepatobiliary disorders Biliary dilatation	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Hepatobiliary disorders Biliary obstruction	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.47% 2/429 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Hepatobiliary disorders Cholangitis	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Hepatobiliary disorders Cholangitis sclerosing	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Hepatobiliary disorders Cholecystitis	0.45% 2/441 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Hepatobiliary disorders Cholecystitis acute	0.91% 4/441 • Number of events 4 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Hepatobiliary disorders Cholestasis	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Hepatobiliary disorders Gallbladder rupture	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Hepatobiliary disorders Hepatic failure	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.70% 3/429 • Number of events 3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Hepatobiliary disorders Hepatic haemorrhage	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Hepatobiliary disorders Hepatitis	0.45% 2/441 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Hepatobiliary disorders Hypertransaminasaemia	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Hepatobiliary disorders Immune-mediated hepatitis	0.45% 2/441 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Hepatobiliary disorders Jaundice cholestatic	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Hepatobiliary disorders Liver injury	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Immune system disorders Anaphylactic reaction	0.45% 2/441 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Immune system disorders Anaphylactic shock	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Immune system disorders Drug hypersensitivity	0.45% 2/441 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Abdominal infection	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Abdominal sepsis	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Anal abscess	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Bacteraemia	0.45% 2/441 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Biliary tract infection	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations COVID-19	1.1% 5/441 • Number of events 5 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations COVID-19 pneumonia	0.91% 4/441 • Number of events 4 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.47% 2/429 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Clostridium difficile infection	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Device related infection	1.1% 5/441 • Number of events 5 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Encephalitis	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Endocarditis	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Escherichia bacteraemia	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Escherichia infection	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Fungaemia	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Gastroenteritis	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Haematological infection	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Herpes virus infection	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Infection	0.45% 2/441 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Infectious pleural effusion	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Lower respiratory tract infection	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Lung abscess	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Meningitis aseptic	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Neutropenic infection	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Oesophageal candidiasis	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Pneumonia	0.91% 4/441 • Number of events 5 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	2.3% 10/429 • Number of events 11 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Pneumonia bacterial	0.45% 2/441 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Pulmonary tuberculosis	0.45% 2/441 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Sepsis	1.1% 5/441 • Number of events 5 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.47% 2/429 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Septic shock	0.68% 3/441 • Number of events 3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Soft tissue infection	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Staphylococcal sepsis	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Tonsillitis	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Tuberculosis	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Upper respiratory tract infection	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Urinary tract infection	1.1% 5/441 • Number of events 5 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.47% 2/429 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Urinary tract infection staphylococcal	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Urosepsis	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.47% 2/429 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Injury, poisoning and procedural complications Eschar	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Injury, poisoning and procedural complications Infusion related reaction	0.45% 2/441 • Number of events 3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Injury, poisoning and procedural complications Pneumonitis chemical	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Injury, poisoning and procedural complications Rib fracture	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Amylase increased	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Aspartate aminotransferase increased	0.45% 2/441 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Blood bilirubin increased	0.68% 3/441 • Number of events 3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Blood creatinine increased	0.45% 2/441 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Blood potassium decreased	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Lipase increased	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Lymphocyte count decreased	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Neutrophil count decreased	0.68% 3/441 • Number of events 3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.93% 4/429 • Number of events 4 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Platelet count decreased	0.91% 4/441 • Number of events 4 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	2.3% 10/429 • Number of events 11 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations SARS-CoV-2 test positive	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations White blood cell count decreased	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.47% 2/429 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Cachexia	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Decreased appetite	0.68% 3/441 • Number of events 3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Dehydration	1.1% 5/441 • Number of events 5 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.47% 2/429 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Electrolyte imbalance	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Hypoglycaemia	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Hypokalaemia	0.68% 3/441 • Number of events 3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Hyponatraemia	1.4% 6/441 • Number of events 6 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.47% 2/429 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Malnutrition	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.45% 2/441 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Muscular weakness	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Myopathy	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Pathological fracture	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Nervous system disorders Cerebral ischaemia	0.45% 2/441 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.47% 2/429 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.68% 3/441 • Number of events 3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour perforation	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Nervous system disorders Cerebral infarction	0.45% 2/441 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Nervous system disorders Cerebrovascular accident	0.91% 4/441 • Number of events 4 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Nervous system disorders Encephalopathy	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Nervous system disorders Haemorrhage intracranial	0.45% 2/441 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Nervous system disorders Intracranial pressure increased	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Nervous system disorders Neurotoxicity	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Nervous system disorders Seizure	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Nervous system disorders Transient ischaemic attack	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Nervous system disorders Vagus nerve disorder	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Product Issues Device dislocation	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Product Issues Device occlusion	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Psychiatric disorders Bipolar disorder	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Psychiatric disorders Confusional state	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Psychiatric disorders Delirium	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Psychiatric disorders Schizophrenia	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Renal and urinary disorders Acute kidney injury	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.70% 3/429 • Number of events 3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Renal and urinary disorders Hydronephrosis	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.70% 3/429 • Number of events 3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Renal and urinary disorders Immune-mediated nephritis	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Renal and urinary disorders Renal failure	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.47% 2/429 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Renal and urinary disorders Renal impairment	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Renal and urinary disorders Tubulointerstitial nephritis	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Renal and urinary disorders Urinary tract obstruction	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Reproductive system and breast disorders Haemorrhagic ovarian cyst	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Reproductive system and breast disorders Prostatitis	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Aspiration	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Dysaesthesia pharynx	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Skin and subcutaneous tissue disorders Rash	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Laryngospasm	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Malignant pleural effusion	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.47% 2/429 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.6% 7/441 • Number of events 7 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	2.1% 9/429 • Number of events 9 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Pulmonary toxicity	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Skin and subcutaneous tissue disorders Dermatitis bullous	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Skin and subcutaneous tissue disorders Erythema multiforme	0.45% 2/441 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Skin and subcutaneous tissue disorders Toxic epidermal necrolysis	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Vascular disorders Deep vein thrombosis	0.68% 3/441 • Number of events 3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.70% 3/429 • Number of events 3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Vascular disorders Embolism	0.45% 2/441 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Vascular disorders Embolism arterial	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Vascular disorders Embolism venous	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Vascular disorders Hypertension	0.68% 3/441 • Number of events 3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Vascular disorders Hypovolaemic shock	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Vascular disorders Jugular vein thrombosis	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Vascular disorders Peripheral ischaemia	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Vascular disorders Shock	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Vascular disorders Vasculitis	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Vascular disorders Venous thrombosis limb	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.

Other adverse events

Other adverse events
Measure	Part 2: Lenvatinib + Pembrolizumab + Chemotherapy First Course n=441 participants at risk Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab (plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).	Chemotherapy First Course n=429 participants at risk Participants received chemotherapy with either CAPOX Q3W or mFOLFOX6 Q2W. A cycle is 6 weeks (42 days).	Part 1: Lenvatinib + Pembrolizumab + Chemotherapy First Course n=15 participants at risk Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).	Part 1: Pembrolizumab +/-Lenvatinib Second Course n=1 participants at risk Participants treated with pembrolizumab who completed 18 cycles of treatment with SD or better, or participants who attained an investigator-determined CR and received at least 4 cycles of pembrolizumab were eligible for retreatment with up to an additional 9 cycles of pembrolizumab if they experienced radiographic disease progression confirmed by BICR after stopping treatment in the initial treatment phase. Lenvatinib was administered per investigator's discretion	Part 2: Pembrolizumab +/-Lenvatinib Second Course n=3 participants at risk Participants treated with pembrolizumab who completed 18 cycles of treatment with SD or better, or participants who attained an investigator-determined CR and received at least 4 cycles of pembrolizumab were eligible for retreatment with up to an additional 9 cycles of pembrolizumab if they experience radiographic disease progression confirmed by BICR after stopping treatment in the initial treatment phase. Lenvatinib was administered per investigator's discretion
Blood and lymphatic system disorders Anaemia	36.1% 159/441 • Number of events 249 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	37.5% 161/429 • Number of events 241 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	13.3% 2/15 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Blood and lymphatic system disorders Neutropenia	0.45% 2/441 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Cardiac disorders Sinus tachycardia	2.3% 10/441 • Number of events 11 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Endocrine disorders Hyperthyroidism	7.0% 31/441 • Number of events 31 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	1.6% 7/429 • Number of events 8 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	13.3% 2/15 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Endocrine disorders Hypothyroidism	28.8% 127/441 • Number of events 139 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	1.2% 5/429 • Number of events 5 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	26.7% 4/15 • Number of events 4 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Abdominal distension	5.7% 25/441 • Number of events 27 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	4.2% 18/429 • Number of events 23 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Abdominal pain	20.4% 90/441 • Number of events 110 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	16.6% 71/429 • Number of events 86 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Abdominal pain upper	8.2% 36/441 • Number of events 39 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	4.9% 21/429 • Number of events 30 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Ascites	3.4% 15/441 • Number of events 17 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	5.1% 22/429 • Number of events 24 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Constipation	23.6% 104/441 • Number of events 130 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	20.5% 88/429 • Number of events 115 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	13.3% 2/15 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Diarrhoea	45.6% 201/441 • Number of events 339 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	28.7% 123/429 • Number of events 192 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	46.7% 7/15 • Number of events 11 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Dry mouth	6.6% 29/441 • Number of events 30 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	1.6% 7/429 • Number of events 7 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Dyspepsia	5.0% 22/441 • Number of events 25 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	4.4% 19/429 • Number of events 22 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Dysphagia	6.1% 27/441 • Number of events 27 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	4.7% 20/429 • Number of events 23 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	13.3% 2/15 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Flatulence	2.3% 10/441 • Number of events 11 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	2.6% 11/429 • Number of events 13 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Mouth haemorrhage	0.45% 2/441 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Nausea	44.4% 196/441 • Number of events 290 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	45.0% 193/429 • Number of events 295 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	53.3% 8/15 • Number of events 14 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Stomatitis	15.6% 69/441 • Number of events 75 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.3% 40/429 • Number of events 49 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	20.0% 3/15 • Number of events 3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Vomiting	24.9% 110/441 • Number of events 166 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	24.5% 105/429 • Number of events 147 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	46.7% 7/15 • Number of events 14 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
General disorders Asthenia	16.8% 74/441 • Number of events 92 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	16.1% 69/429 • Number of events 100 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 5/15 • Number of events 6 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
General disorders Fatigue	29.3% 129/441 • Number of events 162 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	18.4% 79/429 • Number of events 104 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	13.3% 2/15 • Number of events 4 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
General disorders Mucosal inflammation	11.6% 51/441 • Number of events 62 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.1% 26/429 • Number of events 30 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	13.3% 2/15 • Number of events 4 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
General disorders Oedema peripheral	6.8% 30/441 • Number of events 36 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	5.8% 25/429 • Number of events 28 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
General disorders Pyrexia	13.4% 59/441 • Number of events 83 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	8.4% 36/429 • Number of events 55 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
General disorders Temperature intolerance	0.45% 2/441 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
General disorders Xerosis	2.7% 12/441 • Number of events 13 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	2.6% 11/429 • Number of events 13 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Hepatobiliary disorders Liver disorder	2.3% 10/441 • Number of events 11 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.93% 4/429 • Number of events 4 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Immune system disorders Hypersensitivity	1.1% 5/441 • Number of events 5 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	2.3% 10/429 • Number of events 12 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations COVID-19	10.2% 45/441 • Number of events 48 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	10.0% 43/429 • Number of events 44 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Candida infection	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Gingivitis	0.45% 2/441 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.47% 2/429 • Number of events 4 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	13.3% 2/15 • Number of events 3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Herpes simplex	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Impetigo	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Pneumocystis jirovecii pneumonia	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Urinary tract infection	7.3% 32/441 • Number of events 51 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	3.0% 13/429 • Number of events 16 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Vaginal infection	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Alanine aminotransferase increased	21.3% 94/441 • Number of events 128 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	17.7% 76/429 • Number of events 126 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	26.7% 4/15 • Number of events 4 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Amylase increased	12.5% 55/441 • Number of events 85 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	8.9% 38/429 • Number of events 56 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	13.3% 2/15 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Aspartate aminotransferase increased	24.7% 109/441 • Number of events 159 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	23.8% 102/429 • Number of events 162 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	20.0% 3/15 • Number of events 3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Blood albumin decreased	4.3% 19/441 • Number of events 30 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	3.5% 15/429 • Number of events 23 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	13.3% 2/15 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Blood alkaline phosphatase increased	7.5% 33/441 • Number of events 41 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	10.3% 44/429 • Number of events 50 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Blood bilirubin increased	11.8% 52/441 • Number of events 86 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	11.2% 48/429 • Number of events 77 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	13.3% 2/15 • Number of events 3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Blood calcium decreased	1.6% 7/441 • Number of events 8 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	1.6% 7/429 • Number of events 12 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Blood creatinine increased	7.3% 32/441 • Number of events 39 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	1.6% 7/429 • Number of events 8 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	13.3% 2/15 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Blood folate decreased	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Blood glucose increased	1.6% 7/441 • Number of events 15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	2.6% 11/429 • Number of events 19 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	13.3% 2/15 • Number of events 4 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Blood iron decreased	0.91% 4/441 • Number of events 4 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.70% 3/429 • Number of events 5 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Blood potassium decreased	1.8% 8/441 • Number of events 9 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	2.1% 9/429 • Number of events 11 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	13.3% 2/15 • Number of events 5 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Blood sodium decreased	3.6% 16/441 • Number of events 22 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	1.6% 7/429 • Number of events 18 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	13.3% 2/15 • Number of events 4 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Blood thyroid stimulating hormone increased	9.8% 43/441 • Number of events 64 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	2.6% 11/429 • Number of events 14 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	13.3% 2/15 • Number of events 3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Electrocardiogram QT prolonged	2.0% 9/441 • Number of events 13 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Lipase increased	14.1% 62/441 • Number of events 87 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	13.3% 57/429 • Number of events 86 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	26.7% 4/15 • Number of events 7 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Lymphocyte count decreased	5.2% 23/441 • Number of events 39 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	5.6% 24/429 • Number of events 32 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Neutrophil count decreased	47.4% 209/441 • Number of events 398 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	45.5% 195/429 • Number of events 466 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	46.7% 7/15 • Number of events 11 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Platelet count decreased	29.3% 129/441 • Number of events 236 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	42.0% 180/429 • Number of events 353 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	13.3% 2/15 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Weight decreased	33.6% 148/441 • Number of events 174 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	22.4% 96/429 • Number of events 108 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations White blood cell count decreased	25.9% 114/441 • Number of events 233 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	21.7% 93/429 • Number of events 256 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	13.3% 2/15 • Number of events 3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Decreased appetite	39.2% 173/441 • Number of events 208 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	27.3% 117/429 • Number of events 153 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 5/15 • Number of events 8 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Dehydration	4.8% 21/441 • Number of events 27 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	1.6% 7/429 • Number of events 10 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Hyperglycaemia	8.2% 36/441 • Number of events 58 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.1% 26/429 • Number of events 37 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Hypoalbuminaemia	12.7% 56/441 • Number of events 80 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	12.1% 52/429 • Number of events 74 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Hypocalcaemia	6.3% 28/441 • Number of events 39 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	4.7% 20/429 • Number of events 28 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Hypokalaemia	16.1% 71/441 • Number of events 128 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	10.3% 44/429 • Number of events 61 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Hypomagnesaemia	6.3% 28/441 • Number of events 39 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	3.5% 15/429 • Number of events 20 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Hyponatraemia	7.7% 34/441 • Number of events 43 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	5.8% 25/429 • Number of events 25 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Arthralgia	10.9% 48/441 • Number of events 59 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	4.2% 18/429 • Number of events 18 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	13.3% 2/15 • Number of events 3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Arthritis	2.0% 9/441 • Number of events 9 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Back pain	8.2% 36/441 • Number of events 39 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.3% 27/429 • Number of events 32 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Muscle spasms	2.0% 9/441 • Number of events 11 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	1.4% 6/429 • Number of events 6 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Myalgia	6.1% 27/441 • Number of events 32 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	1.2% 5/429 • Number of events 5 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	0.45% 2/441 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Periarthritis	0.45% 2/441 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	2.0% 9/441 • Number of events 9 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.70% 3/429 • Number of events 3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Nervous system disorders Dizziness	5.0% 22/441 • Number of events 22 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.1% 26/429 • Number of events 29 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Nervous system disorders Dysaesthesia	1.4% 6/441 • Number of events 7 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	1.6% 7/429 • Number of events 9 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Nervous system disorders Dysgeusia	6.1% 27/441 • Number of events 29 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.6% 41/429 • Number of events 45 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Nervous system disorders Headache	5.9% 26/441 • Number of events 31 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	4.4% 19/429 • Number of events 21 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	20.0% 3/15 • Number of events 5 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Nervous system disorders Neuropathy peripheral	16.6% 73/441 • Number of events 89 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	24.0% 103/429 • Number of events 132 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 5/15 • Number of events 6 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Nervous system disorders Neurotoxicity	1.6% 7/441 • Number of events 12 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	4.0% 17/429 • Number of events 37 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Nervous system disorders Paraesthesia	6.1% 27/441 • Number of events 36 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	8.4% 36/429 • Number of events 67 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Nervous system disorders Peripheral sensory neuropathy	12.2% 54/441 • Number of events 61 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	18.9% 81/429 • Number of events 89 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Psychiatric disorders Insomnia	7.0% 31/441 • Number of events 32 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.1% 26/429 • Number of events 30 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Renal and urinary disorders Proteinuria	22.4% 99/441 • Number of events 188 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	1.4% 6/429 • Number of events 6 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Reproductive system and breast disorders Intermenstrual bleeding	0.00% 0/441 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Cough	6.3% 28/441 • Number of events 31 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	5.1% 22/429 • Number of events 23 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Dysaesthesia pharynx	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.70% 3/429 • Number of events 4 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Dysphonia	5.4% 24/441 • Number of events 25 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	1.4% 6/429 • Number of events 7 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.7% 25/441 • Number of events 26 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	2.8% 12/429 • Number of events 12 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.2% 23/441 • Number of events 25 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	5.1% 22/429 • Number of events 26 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	13.3% 2/15 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Hiccups	3.6% 16/441 • Number of events 23 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	4.4% 19/429 • Number of events 25 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.68% 3/441 • Number of events 3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Laryngospasm	0.23% 1/441 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.23% 1/429 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Skin and subcutaneous tissue disorders Alopecia	2.7% 12/441 • Number of events 13 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	3.3% 14/429 • Number of events 15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Skin and subcutaneous tissue disorders Dermatitis acneiform	2.3% 10/441 • Number of events 10 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.47% 2/429 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Skin and subcutaneous tissue disorders Drug eruption	0.45% 2/441 • Number of events 3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	22.0% 97/441 • Number of events 114 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	14.0% 60/429 • Number of events 71 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	40.0% 6/15 • Number of events 8 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Skin and subcutaneous tissue disorders Pruritus	11.6% 51/441 • Number of events 69 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	3.5% 15/429 • Number of events 17 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Skin and subcutaneous tissue disorders Rash	12.0% 53/441 • Number of events 67 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	4.0% 17/429 • Number of events 21 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	13.3% 2/15 • Number of events 2 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Vascular disorders Hypertension	33.1% 146/441 • Number of events 218 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	5.1% 22/429 • Number of events 27 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	26.7% 4/15 • Number of events 4 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Vascular disorders Hypotension	2.7% 12/441 • Number of events 12 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	2.8% 12/429 • Number of events 12 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/15 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Vascular disorders Thrombosis	0.68% 3/441 • Number of events 3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/429 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.7% 1/15 • Number of events 1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.

Additional Information

Senior Vice President, Global 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