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: 2025-11-28

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

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

895 participants

Primary outcome timeframe

Up to ~21 days

Results posted on

2025-11-28

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 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).	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).
Overall Study STARTED	15	443	437
Overall Study Treated	15	441	429
Overall Study Received Second Course of Pembrolizumab +/- Lenvatinib	1	3	0
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	15	443	437

Reasons for withdrawal

Reasons for withdrawal
Measure	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).	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).
Overall Study Death	14	331	367
Overall Study Ongoing	1	109	56
Overall Study Withdrawal by Subject	0	3	14

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=30 Participants	59.7 Years STANDARD_DEVIATION 12.5 • n=30 Participants	59.1 Years STANDARD_DEVIATION 12.0 • n=60 Participants	59.3 Years STANDARD_DEVIATION 12.3 • n=92 Participants
Sex: Female, Male Female	8 Participants n=30 Participants	151 Participants n=30 Participants	131 Participants n=60 Participants	290 Participants n=92 Participants
Sex: Female, Male Male	7 Participants n=30 Participants	292 Participants n=30 Participants	306 Participants n=60 Participants	605 Participants n=92 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=30 Participants	116 Participants n=30 Participants	115 Participants n=60 Participants	238 Participants n=92 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=30 Participants	319 Participants n=30 Participants	313 Participants n=60 Participants	640 Participants n=92 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=30 Participants	8 Participants n=30 Participants	9 Participants n=60 Participants	17 Participants n=92 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=30 Participants	11 Participants n=30 Participants	15 Participants n=60 Participants	26 Participants n=92 Participants
Race (NIH/OMB) Asian	4 Participants n=30 Participants	164 Participants n=30 Participants	161 Participants n=60 Participants	329 Participants n=92 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants	0 Participants n=92 Participants
Race (NIH/OMB) Black or African American	0 Participants n=30 Participants	1 Participants n=30 Participants	1 Participants n=60 Participants	2 Participants n=92 Participants
Race (NIH/OMB) White	11 Participants n=30 Participants	235 Participants n=30 Participants	223 Participants n=60 Participants	469 Participants n=92 Participants
Race (NIH/OMB) More than one race	0 Participants n=30 Participants	30 Participants n=30 Participants	36 Participants n=60 Participants	66 Participants n=92 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=30 Participants	2 Participants n=30 Participants	1 Participants n=60 Participants	3 Participants n=92 Participants
Geographic Region of Enrolling Site East Asia	4 Participants n=30 Participants	161 Participants n=30 Participants	160 Participants n=60 Participants	325 Participants n=92 Participants
Geographic Region of Enrolling Site North America + Western Europe	5 Participants n=30 Participants	125 Participants n=30 Participants	122 Participants n=60 Participants	252 Participants n=92 Participants
Geographic Region of Enrolling Site Rest of the World	6 Participants n=30 Participants	157 Participants n=30 Participants	155 Participants n=60 Participants	318 Participants n=92 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG 0	11 Participants n=30 Participants	204 Participants n=30 Participants	204 Participants n=60 Participants	419 Participants n=92 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG 1	4 Participants n=30 Participants	239 Participants n=30 Participants	233 Participants n=60 Participants	476 Participants n=92 Participants
Intended Chemotherapy CAPOX	7 Participants n=30 Participants	232 Participants n=30 Participants	225 Participants n=60 Participants	464 Participants n=92 Participants
Intended Chemotherapy mFOLFOX6	8 Participants n=30 Participants	209 Participants n=30 Participants	204 Participants n=60 Participants	421 Participants n=92 Participants
Intended Chemotherapy Missing	0 Participants n=30 Participants	2 Participants n=30 Participants	8 Participants n=60 Participants	10 Participants n=92 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 1: Lenvatinib + Pembrolizumab + Chemotherapy First Course

Serious events: 6 serious events

Other events: 14 other events

Deaths: 13 deaths

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: 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 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 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: 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	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.	0.68% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.45% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.91% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.45% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.68% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.91% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.91% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.45% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.45% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.45% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	0.68% 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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.45% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.68% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.68% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.45% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.45% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.45% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.91% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.45% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.91% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.45% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.45% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.91% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.45% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.45% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.45% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.45% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.45% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.91% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.45% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	0.91% 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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.45% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.45% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.68% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.45% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.45% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.68% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.45% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.68% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.91% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.68% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.68% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.45% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.45% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.68% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.45% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.91% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.45% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.45% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.68% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.45% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.68% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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 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 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: 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	0.45% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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.	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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	6.7% 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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	0.45% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	0.45% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	0.45% 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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	0.23% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	0.91% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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% 0/15 • 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.	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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	0.00% 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.	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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	6.7% 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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	0.45% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	0.45% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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% 0/441 • 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	0.23% 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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	0.68% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	0.23% 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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	0.45% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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.	0.00% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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	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.	0.68% 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% 0/1 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Up to approximately 44 months All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 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