Trial Outcomes & Findings for A Study to Evaluate the Safety and Tolerability of RO7296682 in Participants With Advanced Solid Tumors (NCT NCT04158583)

Last Updated: 2024-03-04

Results Overview

An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product. An AE does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

76 participants

Primary outcome timeframe

From signing of informed consent form (ICF) until last follow-up visit (Up to approximately 2 years 7 months)

Results posted on

2024-03-04

Participant Flow

Participants took part in Part A of the study at 11 centers in Australia, Belgium, Canada, Denmark and Spain from 09 December 2019 to 21 July 2022. The study was terminated before Part B was initiated.

A total of 76 participants with non-small cell lung cancer (NSCLC), melanoma (MEL), head and neck squamous cell carcinoma (HNSCC), ovarian cancer (OvC), triple-negative breast cancer (TNBC), and esophageal carcinoma (EsC) were enrolled in Part A. No Participants were enrolled in Part B.

Participant milestones

Participant milestones
Measure	Part A: Cohort 1 RO7296682 0.3 mg Q3W Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 0.3 mg IV infusion on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 2 RO7296682 1 mg Q3W Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 1 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 3 RO7296682 2 mg Q3W Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 2 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 4 RO7296682 6 mg Q3W Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 6 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 5 RO7296682 18 mg Q3W Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 18 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 6 RO7296682 35 mg Q3W Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 35 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 7 RO7296682 70 mg Q3W Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 70 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 8 RO7296682 100 mg Q3W Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 100 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 9 RO7296682 165 mg Q3W Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 165 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 10 RO7296682 20 mg Q3W Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 20 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.
Overall Study STARTED	5	5	6	14	8	5	15	6	6	6
Overall Study Pharmacokinetic Population	5	5	6	13	6	5	15	6	6	6
Overall Study COMPLETED	0	0	0	3	1	1	2	2	2	2
Overall Study NOT COMPLETED	5	5	6	11	7	4	13	4	4	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A: Cohort 1 RO7296682 0.3 mg Q3W Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 0.3 mg IV infusion on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 2 RO7296682 1 mg Q3W Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 1 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 3 RO7296682 2 mg Q3W Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 2 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 4 RO7296682 6 mg Q3W Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 6 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 5 RO7296682 18 mg Q3W Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 18 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 6 RO7296682 35 mg Q3W Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 35 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 7 RO7296682 70 mg Q3W Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 70 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 8 RO7296682 100 mg Q3W Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 100 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 9 RO7296682 165 mg Q3W Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 165 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 10 RO7296682 20 mg Q3W Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 20 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.
Overall Study Withdrawal by Subject	1	1	0	0	1	0	0	0	2	0
Overall Study Study Terminated by Sponsor	0	0	0	1	0	0	0	0	0	0
Overall Study Progressive Disease	1	0	3	5	0	1	6	2	1	2
Overall Study Lost to Follow-up	0	0	1	1	1	0	0	0	0	0
Overall Study Due To Patient Status	0	0	0	0	0	0	0	0	1	0
Overall Study Death	3	4	2	2	4	3	5	2	0	1
Overall Study Clinical Progression Disease	0	0	0	1	0	0	0	0	0	0
Overall Study Clinical Progression	0	0	0	0	1	0	2	0	0	0
Overall Study Clinical Deterioration	0	0	0	1	0	0	0	0	0	1

Baseline Characteristics

A Study to Evaluate the Safety and Tolerability of RO7296682 in Participants With Advanced Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A: Cohort 1 RO7296682 0.3 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 0.3 mg IV infusion on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 2 RO7296682 1 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 1 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 3 RO7296682 2 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 2 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 4 RO7296682 6 mg Q3W n=14 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 6 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 5 RO7296682 18 mg Q3W n=8 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 18 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 6 RO7296682 35 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 35 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 7 RO7296682 70 mg Q3W n=15 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 70 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 8 RO7296682 100 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 100 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 9 RO7296682 165 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 165 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 10 RO7296682 20 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 20 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Total n=76 Participants Total of all reporting groups
Age, Continuous	62.0 years STANDARD_DEVIATION 3.1 • n=5 Participants	57.2 years STANDARD_DEVIATION 10.9 • n=7 Participants	56.8 years STANDARD_DEVIATION 17.0 • n=5 Participants	56.4 years STANDARD_DEVIATION 9.4 • n=4 Participants	60.6 years STANDARD_DEVIATION 10.0 • n=21 Participants	55.4 years STANDARD_DEVIATION 9.2 • n=8 Participants	60.3 years STANDARD_DEVIATION 11.0 • n=8 Participants	58.8 years STANDARD_DEVIATION 10.3 • n=24 Participants	57.0 years STANDARD_DEVIATION 14.8 • n=42 Participants	59.5 years STANDARD_DEVIATION 14.4 • n=42 Participants	58.5 years STANDARD_DEVIATION 10.8 • n=42 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants	5 Participants n=21 Participants	3 Participants n=8 Participants	8 Participants n=8 Participants	4 Participants n=24 Participants	4 Participants n=42 Participants	4 Participants n=42 Participants	43 Participants n=42 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	7 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=8 Participants	7 Participants n=8 Participants	2 Participants n=24 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants	33 Participants n=42 Participants
Race/Ethnicity, Customized Race · Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	6 Participants n=42 Participants
Race/Ethnicity, Customized Race · White	5 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	13 Participants n=4 Participants	6 Participants n=21 Participants	5 Participants n=8 Participants	15 Participants n=8 Participants	5 Participants n=24 Participants	5 Participants n=42 Participants	5 Participants n=42 Participants	70 Participants n=42 Participants
Race/Ethnicity, Customized Ethnicity · Not Hispanic or Latino	5 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	12 Participants n=4 Participants	7 Participants n=21 Participants	5 Participants n=8 Participants	14 Participants n=8 Participants	6 Participants n=24 Participants	6 Participants n=42 Participants	5 Participants n=42 Participants	70 Participants n=42 Participants
Race/Ethnicity, Customized Ethnicity · Not Stated	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	4 Participants n=42 Participants
Race/Ethnicity, Customized Ethnicity · Unknown	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants

PRIMARY outcome

Timeframe: From signing of informed consent form (ICF) until last follow-up visit (Up to approximately 2 years 7 months)

Population: Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.

Outcome measures

Outcome measures
Measure	Part A: Cohort 1 RO7296682 0.3 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 0.3 mg IV infusion on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 2 RO7296682 1 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 1 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 3 RO7296682 2 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 2 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 4 RO7296682 6 mg Q3W n=14 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 6 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 5 RO7296682 18 mg Q3W n=8 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 18 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 6 RO7296682 35 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 35 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 7 RO7296682 70 mg Q3W n=15 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 70 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 8 RO7296682 100 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 100 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 9 RO7296682 165 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 165 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 10 RO7296682 20 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 20 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.
Number of Participants With Adverse Events (AE) Determined According to The National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v5.0)	5 Participants	5 Participants	6 Participants	14 Participants	8 Participants	5 Participants	14 Participants	6 Participants	6 Participants	6 Participants

PRIMARY outcome

Timeframe: Up to 28 days

Population: Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.

A DLT was defined as occurrence of a clinically significant adverse event (AE) from first administration of RO7296682 up to 7 days after second administration of RO7296682. DLTs were defined as following: 1) Hematologic toxicities - Grade 4 neutropenia lasting \>=7 days, Grade \>=3 febrile neutropenia, Grade 4 thrombocytopenia lasting \>=48 hours, Grade 3 thrombocytopenia associated with bleeding episode and Grade 4 anemia 2) Nonhematologic toxicities - Grade 3 nausea, vomiting or diarrhea, Grade \>=3 fatigue, Grade 3 arthralgia, fever \>40 degree Celsius occurs within 48 hours, Grade \>+ laboratory abnormalities, Grade 3 autoimmune thyroiditis or other endocrine abnormalities, Grade 3 tumor flare, Grade 3 transient increase of bilirubin in participants with liver lesions, transaminases (aspartate aminotransferase \[AST\]/alanine aminotransferase \[ALT\]) and/or gamma-glutamyl transferase (GGT) and any other RO7296682-related toxicity significant enough to be qualified as DLT.

Outcome measures

Outcome measures
Measure	Part A: Cohort 1 RO7296682 0.3 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 0.3 mg IV infusion on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 2 RO7296682 1 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 1 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 3 RO7296682 2 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 2 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 4 RO7296682 6 mg Q3W n=14 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 6 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 5 RO7296682 18 mg Q3W n=8 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 18 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 6 RO7296682 35 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 35 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 7 RO7296682 70 mg Q3W n=15 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 70 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 8 RO7296682 100 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 100 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 9 RO7296682 165 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 165 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 10 RO7296682 20 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 20 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.
Number of Participants With Dose Limiting Toxicities (DLTs)	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	3 Participants	0 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: From treatment initiation until last follow-up visit (Up to approximately 2 years 7 months )

Population: Intent-to Treat (ITT) population included all participants who received at least one dose of RO7296682, and who had at least one baseline and one on-study tumor assessment. Participants who received at least one dose of study drug and discontinued the study because of progression before the first on-study tumor assessment were considered as response-evaluable were included in the efficacy analyses. Participants with missing or no response assessments were classified as not evaluable.

ORR is defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigators' assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. CR is the disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to \< 10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the Baseline sum diameters in the absence of CR.

Outcome measures

Outcome measures
Measure	Part A: Cohort 1 RO7296682 0.3 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 0.3 mg IV infusion on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 2 RO7296682 1 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 1 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 3 RO7296682 2 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 2 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 4 RO7296682 6 mg Q3W n=14 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 6 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 5 RO7296682 18 mg Q3W n=8 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 18 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 6 RO7296682 35 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 35 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 7 RO7296682 70 mg Q3W n=15 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 70 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 8 RO7296682 100 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 100 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 9 RO7296682 165 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 165 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 10 RO7296682 20 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 20 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.
Objective Response Rate (ORR)	0 percentage of participants Interval 0.0 to 52.18	0 percentage of participants Interval 0.0 to 52.18	0 percentage of participants Interval 0.0 to 45.93	0 percentage of participants Interval 0.0 to 23.16	0 percentage of participants Interval 0.0 to 36.94	0 percentage of participants Interval 0.0 to 52.18	0 percentage of participants Interval 0.0 to 21.8	0 percentage of participants Interval 0.0 to 45.93	0 percentage of participants Interval 0.0 to 45.93	0 percentage of participants Interval 0.0 to 45.93

SECONDARY outcome

Timeframe: From treatment initiation until last follow-up visit (Up to approximately 2 years 7 months)

Population: ITT population included all participants who received at least one dose of RO7296682, and who had at least one baseline and one on-study tumor assessment. Participants who received at least one dose of study drug and discontinued the study because of progression before the first on-study tumor assessment were considered as response-evaluable were included in the efficacy analyses. Participants with missing or no response assessments were classified as not evaluable.

DCR defined as the percentage of participants with an overall response of either CR, PR, or stable disease (SD), based on Investigators' assessment using RECIST Version 1.1. CR is defined as disappearance of all target lesions. any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PD is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for (PD). PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline (nadir).

Outcome measures

Outcome measures
Measure	Part A: Cohort 1 RO7296682 0.3 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 0.3 mg IV infusion on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 2 RO7296682 1 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 1 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 3 RO7296682 2 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 2 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 4 RO7296682 6 mg Q3W n=14 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 6 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 5 RO7296682 18 mg Q3W n=8 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 18 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 6 RO7296682 35 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 35 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 7 RO7296682 70 mg Q3W n=15 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 70 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 8 RO7296682 100 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 100 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 9 RO7296682 165 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 165 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 10 RO7296682 20 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 20 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.
Disease Control Rate (DCR)	40.0 percentage of participants Interval 5.27 to 85.34	20.0 percentage of participants Interval 0.51 to 71.64	33.3 percentage of participants Interval 4.33 to 77.72	14.3 percentage of participants Interval 1.78 to 42.81	37.5 percentage of participants Interval 8.52 to 75.51	20.0 percentage of participants Interval 0.51 to 71.64	33.3 percentage of participants Interval 11.82 to 61.62	33.3 percentage of participants Interval 4.33 to 77.72	66.7 percentage of participants Interval 22.28 to 95.67	0 percentage of participants Interval 0.0 to 45.93

SECONDARY outcome

Timeframe: From treatment initiation until last follow-up visit (Up to approximately 2 years 7 months)

Population: Participants who received at least one dose of study drug and discontinued the study because of progression before the first on-study tumor assessment were considered as response-evaluable were included in the efficacy analyses. No participants had an objective response, Hence DOR could not be measured.

DOR is defined as the time from first occurrence of a documented objective response to disease progression as determined by the investigator according to RECIST v1.1. or death from any cause, whichever occurs first. Objective response is defined as the percentage of participants having a CR or PR as determined by investigators' assessment of radiographic disease per RECIST v1.1. CR is the disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the SOD of target lesions, taking as reference the Baseline sum diameters in the absence of CR.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From treatment initiation until last follow-up visit (Up to approximately 2 years 7 months)

The PFS on treatment was defined as the time from study treatment initiation (Cycle 1 Day 1, (1 cycle=21 days) ) to the first occurrence of documented disease progression based on RECIST Version 1.1 Investigator's assessment, or death from any cause, whichever occurred first. For participants who did not have documented progressive disease or death (within 30 days from last study treatment) during the study, PFS was censored at the day of the last tumor assessment. Participants without any post baseline assessments or with all post-baseline assessments having unknown result/response but known to be alive at the clinical cut off for the analysis would be censored at the date of study treatment initiation plus one day.

Outcome measures

Outcome measures
Measure	Part A: Cohort 1 RO7296682 0.3 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 0.3 mg IV infusion on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 2 RO7296682 1 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 1 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 3 RO7296682 2 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 2 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 4 RO7296682 6 mg Q3W n=14 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 6 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 5 RO7296682 18 mg Q3W n=8 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 18 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 6 RO7296682 35 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 35 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 7 RO7296682 70 mg Q3W n=15 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 70 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 8 RO7296682 100 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 100 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 9 RO7296682 165 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 165 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 10 RO7296682 20 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 20 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.
On-Treatment Progression Free Survival (PFS)	59.0 days Interval 32.0 to Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.	59.0 days Interval 44.0 to Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.	43.5 days Interval 32.0 to 60.0	55.5 days Interval 50.0 to 57.0	56.5 days Interval 15.0 to Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.	55.0 days Interval 26.0 to Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.	57.0 days Interval 51.0 to 63.0	58.0 days Interval 52.0 to 170.0	113.0 days Interval 56.0 to Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.	54.0 days Interval 39.0 to 57.0

SECONDARY outcome

Timeframe: Cycles 1, and 3 or 4 (Cycle length = 21 days)

Population: Pharmacokinetic population included all participants who received at least one dose of study treatment and who had data from at least one post-dose sample. Number analyzed is the number of participants with data available for analysis.

Outcome measures

Outcome measures
Measure	Part A: Cohort 1 RO7296682 0.3 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 0.3 mg IV infusion on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 2 RO7296682 1 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 1 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 3 RO7296682 2 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 2 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 4 RO7296682 6 mg Q3W n=13 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 6 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 5 RO7296682 18 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 18 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 6 RO7296682 35 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 35 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 7 RO7296682 70 mg Q3W n=15 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 70 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 8 RO7296682 100 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 100 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 9 RO7296682 165 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 165 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 10 RO7296682 20 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 20 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.
Area Under the Serum Concentration Time Curve (AUC) of RO7296682 Cycle 1	12.6 hourmicrograms per milliliter(hμg/mL) Geometric Coefficient of Variation 46.0	46.9 hourmicrograms per milliliter(hμg/mL) Geometric Coefficient of Variation 8.7	104 hourmicrograms per milliliter(hμg/mL) Geometric Coefficient of Variation 33.4	280 hourmicrograms per milliliter(hμg/mL) Geometric Coefficient of Variation 29.5	980 hourmicrograms per milliliter(hμg/mL) Geometric Coefficient of Variation 41.1	1750 hourmicrograms per milliliter(hμg/mL) Geometric Coefficient of Variation 23.2	3940 hourmicrograms per milliliter(hμg/mL) Geometric Coefficient of Variation 29.6	5920 hourmicrograms per milliliter(hμg/mL) Geometric Coefficient of Variation 38.8	10600 hourmicrograms per milliliter(hμg/mL) Geometric Coefficient of Variation 34.4	1040 hourmicrograms per milliliter(hμg/mL) Geometric Coefficient of Variation 22.7
Area Under the Serum Concentration Time Curve (AUC) of RO7296682 Cycle 3/4	26.5 hourmicrograms per milliliter(hμg/mL) Geometric Coefficient of Variation 52.4	39.8 hourmicrograms per milliliter(hμg/mL) Geometric Coefficient of Variation 63.5	109 hourmicrograms per milliliter(hμg/mL) Geometric Coefficient of Variation 7.2	359 hourmicrograms per milliliter(hμg/mL) Geometric Coefficient of Variation 53.6	1140 hourmicrograms per milliliter(hμg/mL) Geometric Coefficient of Variation 26.3	2510 hourmicrograms per milliliter(hμg/mL) Geometric Coefficient of Variation 19.0	5110 hourmicrograms per milliliter(hμg/mL) Geometric Coefficient of Variation 55.1	8070 hourmicrograms per milliliter(hμg/mL) Geometric Coefficient of Variation 49.6	11900 hourmicrograms per milliliter(hμg/mL) Geometric Coefficient of Variation 37.7	1460 hourmicrograms per milliliter(hμg/mL) Geometric Coefficient of Variation 45.2

SECONDARY outcome

Timeframe: Cycles 3 or 4 (Cycle length = 21 days)

Outcome measures

Outcome measures
Measure	Part A: Cohort 1 RO7296682 0.3 mg Q3W n=3 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 0.3 mg IV infusion on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 2 RO7296682 1 mg Q3W n=2 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 1 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 3 RO7296682 2 mg Q3W n=2 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 2 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 4 RO7296682 6 mg Q3W n=13 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 6 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 5 RO7296682 18 mg Q3W n=2 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 18 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 6 RO7296682 35 mg Q3W n=4 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 35 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 7 RO7296682 70 mg Q3W n=7 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 70 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 8 RO7296682 100 mg Q3W n=4 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 100 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 9 RO7296682 165 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 165 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 10 RO7296682 20 mg Q3W n=4 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 20 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.
Minimum Serum Concentration (Cmin) of RO7296682	NA μg/mL Geometric Coefficient of Variation NA Geometric mean and geometric coefficient of variation could not be calculated due to insufficient number of participants with events.	0.0546 μg/mL Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated due to insufficient number of participants with events.	0.0858 μg/mL Geometric Coefficient of Variation 8.4	0.265 μg/mL Geometric Coefficient of Variation 0.0519	1.02 μg/mL Geometric Coefficient of Variation 32.6	1.40 μg/mL Geometric Coefficient of Variation 29.5	4.77 μg/mL Geometric Coefficient of Variation 72.0	5.83 μg/mL Geometric Coefficient of Variation 126.6	11.4 μg/mL Geometric Coefficient of Variation 47.3	1.11 μg/mL Geometric Coefficient of Variation 51.8

SECONDARY outcome

Timeframe: Cycles 1, and 3 or 4 (Cycle length = 21 days)

Outcome measures

Outcome measures
Measure	Part A: Cohort 1 RO7296682 0.3 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 0.3 mg IV infusion on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 2 RO7296682 1 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 1 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 3 RO7296682 2 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 2 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 4 RO7296682 6 mg Q3W n=13 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 6 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 5 RO7296682 18 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 18 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 6 RO7296682 35 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 35 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 7 RO7296682 70 mg Q3W n=15 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 70 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 8 RO7296682 100 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 100 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 9 RO7296682 165 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 165 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 10 RO7296682 20 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 20 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.
Maximum Serum Concentration (Cmax) of RO7296682 Cycle 1	0.0718 μg/mL Geometric Coefficient of Variation 26.9	0.256 μg/mL Geometric Coefficient of Variation 16.1	0.505 μg/mL Geometric Coefficient of Variation 34.3	1.79 μg/mL Geometric Coefficient of Variation 57.5	5.38 μg/mL Geometric Coefficient of Variation 31.3	9.80 μg/mL Geometric Coefficient of Variation 29.1	22.4 μg/mL Geometric Coefficient of Variation 25.9	38.2 μg/mL Geometric Coefficient of Variation 26.7	75.9 μg/mL Geometric Coefficient of Variation 46.2	7.46 μg/mL Geometric Coefficient of Variation 30.6
Maximum Serum Concentration (Cmax) of RO7296682 Cycle 3/4	0.107 μg/mL Geometric Coefficient of Variation 51.7	0.277 μg/mL Geometric Coefficient of Variation 8.4	0.727 μg/mL Geometric Coefficient of Variation 42.4	2.58 μg/mL Geometric Coefficient of Variation 80.2	5.22 μg/mL Geometric Coefficient of Variation 16.3	14.0 μg/mL Geometric Coefficient of Variation 24.2	24.0 μg/mL Geometric Coefficient of Variation 32.9	41.8 μg/mL Geometric Coefficient of Variation 18.6	72.8 μg/mL Geometric Coefficient of Variation 33.7	7.24 μg/mL Geometric Coefficient of Variation 58.3

SECONDARY outcome

Timeframe: Cycles 1, and 3 or 4 (Cycle length = 21 days)

Outcome measures

Outcome measures
Measure	Part A: Cohort 1 RO7296682 0.3 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 0.3 mg IV infusion on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 2 RO7296682 1 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 1 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 3 RO7296682 2 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 2 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 4 RO7296682 6 mg Q3W n=13 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 6 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 5 RO7296682 18 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 18 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 6 RO7296682 35 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 35 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 7 RO7296682 70 mg Q3W n=15 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 70 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 8 RO7296682 100 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 100 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 9 RO7296682 165 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 165 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 10 RO7296682 20 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 20 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.
Total Clearance (CL) of RO7296682 Cycle 1	23.9 milliliter per hour (mL/h) Geometric Coefficient of Variation 46.0	21.3 milliliter per hour (mL/h) Geometric Coefficient of Variation 8.7	19.3 milliliter per hour (mL/h) Geometric Coefficient of Variation 33.4	21.4 milliliter per hour (mL/h) Geometric Coefficient of Variation 29.5	18.4 milliliter per hour (mL/h) Geometric Coefficient of Variation 41.1	20.0 milliliter per hour (mL/h) Geometric Coefficient of Variation 23.2	17.8 milliliter per hour (mL/h) Geometric Coefficient of Variation 29.6	16.9 milliliter per hour (mL/h) Geometric Coefficient of Variation 38.8	15.5 milliliter per hour (mL/h) Geometric Coefficient of Variation 34.4	19.2 milliliter per hour (mL/h) Geometric Coefficient of Variation 22.7
Total Clearance (CL) of RO7296682 Cycle 3/4	20.7 milliliter per hour (mL/h) Geometric Coefficient of Variation 37.1	25.2 milliliter per hour (mL/h) Geometric Coefficient of Variation 63.5	18.3 milliliter per hour (mL/h) Geometric Coefficient of Variation 7.2	16.7 milliliter per hour (mL/h) Geometric Coefficient of Variation 53.6	15.8 milliliter per hour (mL/h) Geometric Coefficient of Variation 26.3	13.9 milliliter per hour (mL/h) Geometric Coefficient of Variation 19.0	10.9 milliliter per hour (mL/h) Geometric Coefficient of Variation 65.1	12.4 milliliter per hour (mL/h) Geometric Coefficient of Variation 49.6	13.9 milliliter per hour (mL/h) Geometric Coefficient of Variation 37.7	13.7 milliliter per hour (mL/h) Geometric Coefficient of Variation 45.2

SECONDARY outcome

Timeframe: Cycles 1, and 3 or 4 (Cycle length = 21 days)

Outcome measures

Outcome measures
Measure	Part A: Cohort 1 RO7296682 0.3 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 0.3 mg IV infusion on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 2 RO7296682 1 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 1 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 3 RO7296682 2 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 2 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 4 RO7296682 6 mg Q3W n=13 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 6 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 5 RO7296682 18 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 18 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 6 RO7296682 35 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 35 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 7 RO7296682 70 mg Q3W n=15 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 70 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 8 RO7296682 100 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 100 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 9 RO7296682 165 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 165 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 10 RO7296682 20 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 20 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.
Volume of Distribution at Steady State (Vss) of RO7296682 Cycle 1	7480 milliliter (mL) Geometric Coefficient of Variation 61.4	5840 milliliter (mL) Geometric Coefficient of Variation 20.1	7570 milliliter (mL) Geometric Coefficient of Variation 60.8	6150 milliliter (mL) Geometric Coefficient of Variation 23.8	5500 milliliter (mL) Geometric Coefficient of Variation 34.9	6920 milliliter (mL) Geometric Coefficient of Variation 38.3	6140 milliliter (mL) Geometric Coefficient of Variation 29.2	5020 milliliter (mL) Geometric Coefficient of Variation 29.0	4510 milliliter (mL) Geometric Coefficient of Variation 23.5	5650 milliliter (mL) Geometric Coefficient of Variation 16.8
Volume of Distribution at Steady State (Vss) of RO7296682 Cycle 3/4	7340 milliliter (mL) Geometric Coefficient of Variation 24.6	5410 milliliter (mL) Geometric Coefficient of Variation 14.5	5200 milliliter (mL) Geometric Coefficient of Variation 37.6	4710 milliliter (mL) Geometric Coefficient of Variation 34.1	5520 milliliter (mL) Geometric Coefficient of Variation 25.5	4550 milliliter (mL) Geometric Coefficient of Variation 40.6	5030 milliliter (mL) Geometric Coefficient of Variation 18.0	3850 milliliter (mL) Geometric Coefficient of Variation 20.6	4060 milliliter (mL) Geometric Coefficient of Variation 48.6	5240 milliliter (mL) Geometric Coefficient of Variation 18.5

SECONDARY outcome

Timeframe: Cycles 1, and 3 or 4 (Cycle length = 21 days)

Outcome measures

Outcome measures
Measure	Part A: Cohort 1 RO7296682 0.3 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 0.3 mg IV infusion on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 2 RO7296682 1 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 1 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 3 RO7296682 2 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 2 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 4 RO7296682 6 mg Q3W n=13 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 6 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 5 RO7296682 18 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 18 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 6 RO7296682 35 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 35 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 7 RO7296682 70 mg Q3W n=15 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 70 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 8 RO7296682 100 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 100 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 9 RO7296682 165 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 165 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 10 RO7296682 20 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 20 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.
Terminal Half-Life (T1/2) of RO7296682 Cycle 1	286 hours Interval 68.3 to 352.0	213 hours Interval 135.0 to 243.0	382 hours Interval 168.0 to 410.0	204 hours Interval 130.0 to 292.0	241 hours Interval 94.8 to 367.0	264 hours Interval 209.0 to 336.0	232 hours Interval 128.0 to 463.0	199 hours Interval 129.0 to 359.0	198 hours Interval 176.0 to 219.0	242 hours Interval 128.0 to 270.0
Terminal Half-Life (T1/2) of RO7296682 Cycle 3/4	244 hours Interval 241.0 to 246.0	170 hours Interval 89.3 to 252.0	206 hours Interval 157.0 to 255.0	215 hours Interval 93.1 to 318.0	265 hours Interval 169.0 to 361.0	231 hours Interval 171.0 to 356.0	356 hours Interval 152.0 to 642.0	265 hours Interval 118.0 to 309.0	267 hours Interval 105.0 to 281.0	226 hours Interval 219.0 to 489.0

SECONDARY outcome

Timeframe: Cycles 1, and 3 or 4 (Cycle length = 21 days)

Outcome measures

Outcome measures
Measure	Part A: Cohort 1 RO7296682 0.3 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 0.3 mg IV infusion on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 2 RO7296682 1 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 1 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 3 RO7296682 2 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 2 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 4 RO7296682 6 mg Q3W n=13 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 6 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 5 RO7296682 18 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 18 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 6 RO7296682 35 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 35 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 7 RO7296682 70 mg Q3W n=15 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 70 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 8 RO7296682 100 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 100 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 9 RO7296682 165 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 165 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 10 RO7296682 20 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 20 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.
Time of Maximum Concentration (Tmax) of RO7296682 Cycle 1	6.5 hours Interval 3.92 to 7.73	4.05 hours Interval 0.0 to 4.33	5.31 hours Interval 3.67 to 7.0	4.08 hours Interval 3.97 to 46.43	5.36 hours Interval 4.07 to 6.83	4.08 hours Interval 4.0 to 7.23	4.20 hours Interval 2.0 to 6.72	4.20 hours Interval 4.02 to 6.83	4.07 hours Interval 2.0 to 6.73	6.68 hours Interval 2.0 to 21.25
Time of Maximum Concentration (Tmax) of RO7296682 Cycle 3/4	1.00 hours Interval 0.98 to 3.63	2.31 hours Interval 1.12 to 3.5	3.52 hours Interval 3.5 to 3.53	1.08 hours Interval 0.58 to 23.67	1.14 hours Interval 1.08 to 1.2	3.83 hours Interval 3.58 to 24.83	1.05 hours Interval 0.68 to 22.42	2.38 hours Interval 1.07 to 4.65	1.02 hours Interval 1.0 to 3.57	21.57 hours Interval 1.07 to 49.32

SECONDARY outcome

Timeframe: Predose on Day 1 of each 21-day and subsequent cycles up to end of study (Up to approximately 2 years 7 months)

Population: Immunogenicity analyses population included all participants with at least one ADA assessment, irrespective of whether or not the participant received any treatment.

Outcome measures

Outcome measures
Measure	Part A: Cohort 1 RO7296682 0.3 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 0.3 mg IV infusion on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 2 RO7296682 1 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 1 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 3 RO7296682 2 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 2 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 4 RO7296682 6 mg Q3W n=14 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 6 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 5 RO7296682 18 mg Q3W n=8 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 18 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 6 RO7296682 35 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 35 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 7 RO7296682 70 mg Q3W n=15 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 70 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 8 RO7296682 100 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 100 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 9 RO7296682 165 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 165 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 10 RO7296682 20 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 20 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.
Number of Participants With Anti-Drug Antibodies (ADA) During the Study Relative to the Prevalence of ADA at Baseline	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and at Cycle 1 Day 4 (Cycle length = 21 days)

Population: Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Number analyzed is the number of participants with data available for analysis.

Outcome measures

Outcome measures
Measure	Part A: Cohort 1 RO7296682 0.3 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 0.3 mg IV infusion on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 2 RO7296682 1 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 1 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 3 RO7296682 2 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 2 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 4 RO7296682 6 mg Q3W n=14 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 6 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 5 RO7296682 18 mg Q3W n=8 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 18 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 6 RO7296682 35 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 35 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 7 RO7296682 70 mg Q3W n=15 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 70 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 8 RO7296682 100 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 100 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 9 RO7296682 165 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 165 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 10 RO7296682 20 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 20 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.
Treatment-induced Changes in Treg Levels in Blood and/or Tumor as Compared to Baseline %CD4 Treg: Baseline	1.61 percent cells per microliter (cells/µL) Standard Deviation 0.36	2.77 percent cells per microliter (cells/µL) Standard Deviation 1.31	1.94 percent cells per microliter (cells/µL) Standard Deviation 1.54	2.39 percent cells per microliter (cells/µL) Standard Deviation 2.20	1.65 percent cells per microliter (cells/µL) Standard Deviation 1.17	3.40 percent cells per microliter (cells/µL) Standard Deviation 0.25	2.65 percent cells per microliter (cells/µL) Standard Deviation 1.48	1.84 percent cells per microliter (cells/µL) Standard Deviation 0.64	1.92 percent cells per microliter (cells/µL) Standard Deviation 1.51	2.20 percent cells per microliter (cells/µL) Standard Deviation 1.78
Treatment-induced Changes in Treg Levels in Blood and/or Tumor as Compared to Baseline %CD4 Treg: Change from Baseline at Cycle 1 Day 4	0.18 percent cells per microliter (cells/µL) Standard Deviation 2.15	-1.22 percent cells per microliter (cells/µL) Standard Deviation 0.88	-1.17 percent cells per microliter (cells/µL) Standard Deviation 1.33	-1.71 percent cells per microliter (cells/µL) Standard Deviation 1.95	-0.79 percent cells per microliter (cells/µL) Standard Deviation 2.29	-3.02 percent cells per microliter (cells/µL) Standard Deviation 0.56	-2.62 percent cells per microliter (cells/µL) Standard Deviation 1.38	-1.33 percent cells per microliter (cells/µL) Standard Deviation 0.61	-1.98 percent cells per microliter (cells/µL) Standard Deviation 1.04	-1.28 percent cells per microliter (cells/µL) Standard Deviation 1.10

SECONDARY outcome

Timeframe: Baseline and at Cycle 1 Day 4 (Cycle length = 21 days)

Outcome measures

Outcome measures
Measure	Part A: Cohort 1 RO7296682 0.3 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 0.3 mg IV infusion on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 2 RO7296682 1 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 1 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 3 RO7296682 2 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 2 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 4 RO7296682 6 mg Q3W n=14 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 6 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 5 RO7296682 18 mg Q3W n=8 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 18 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 6 RO7296682 35 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 35 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 7 RO7296682 70 mg Q3W n=15 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 70 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 8 RO7296682 100 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 100 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 9 RO7296682 165 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 165 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 10 RO7296682 20 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 20 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.
Treatment-induced Changes in Treg/Teff (T-regulatory Cell; T-effector Cell) Ratio in Blood and/or Tumor as Compared to Baseline Treg/Teff Ratio: Change from Baseline at Cycle 1 Day 4	12.50 ratio Standard Deviation 51.90	19.0 ratio Standard Deviation 131.90	30.0 ratio Standard Deviation 53.35	52.30 ratio Standard Deviation 113.88	-9.17 ratio Standard Deviation 98.55	-5.33 ratio Standard Deviation 33.86	-14.64 ratio Standard Deviation 67.96	-12.33 ratio Standard Deviation 104.22	26.00 ratio Standard Deviation 79.05	-121.00 ratio Standard Deviation 108.75
Treatment-induced Changes in Treg/Teff (T-regulatory Cell; T-effector Cell) Ratio in Blood and/or Tumor as Compared to Baseline Treg/Teff Ratio: Baseline	0.05 ratio Standard Deviation 0.04	0.06 ratio Standard Deviation 0.04	0.10 ratio Standard Deviation 0.09	0.06 ratio Standard Deviation 0.05	0.05 ratio Standard Deviation 0.04	0.10 ratio Standard Deviation 0.06	0.11 ratio Standard Deviation 0.10	0.07 ratio Standard Deviation 0.07	0.04 ratio Standard Deviation 0.04	0.05 ratio Standard Deviation 0.05

Adverse Events

Part A: Cohort 1 RO7296682 0.3 mg Q3W

Serious events: 1 serious events

Other events: 5 other events

Deaths: 3 deaths

Part A: Cohort 2 RO7296682 1 mg Q3W

Serious events: 2 serious events

Other events: 5 other events

Deaths: 4 deaths

Part A: Cohort 3 RO7296682 2 mg Q3W

Serious events: 0 serious events

Other events: 6 other events

Deaths: 5 deaths

Part A: Cohort 4 RO7296682 6 mg Q3W

Serious events: 7 serious events

Other events: 14 other events

Deaths: 7 deaths

Part A: Cohort 5 RO7296682 18 mg Q3W

Serious events: 3 serious events

Other events: 8 other events

Deaths: 5 deaths

Part A: Cohort 6 RO7296682 35 mg Q3W

Serious events: 0 serious events

Other events: 5 other events

Deaths: 4 deaths

Part A: Cohort 7 RO7296682 70 mg Q3W

Serious events: 5 serious events

Other events: 14 other events

Deaths: 10 deaths

Part A: Cohort 8 RO7296682 100 mg Q3W

Serious events: 0 serious events

Other events: 6 other events

Deaths: 4 deaths

Part A: Cohort 9 RO7296682 165 mg Q3W

Serious events: 1 serious events

Other events: 6 other events

Deaths: 1 deaths

Part A: Cohort 10 RO7296682 20 mg Q3W

Serious events: 1 serious events

Other events: 6 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Part A: Cohort 1 RO7296682 0.3 mg Q3W n=5 participants at risk Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 0.3 mg IV infusion on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 2 RO7296682 1 mg Q3W n=5 participants at risk Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 1 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 3 RO7296682 2 mg Q3W n=6 participants at risk Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 2 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 4 RO7296682 6 mg Q3W n=14 participants at risk Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 6 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 5 RO7296682 18 mg Q3W n=8 participants at risk Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 18 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 6 RO7296682 35 mg Q3W n=5 participants at risk Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 35 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 7 RO7296682 70 mg Q3W n=15 participants at risk Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 70 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 8 RO7296682 100 mg Q3W n=6 participants at risk Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 100 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 9 RO7296682 165 mg Q3W n=6 participants at risk Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 165 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 10 RO7296682 20 mg Q3W n=6 participants at risk Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 20 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Vomiting	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 1/8 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
General disorders Fatigue	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
General disorders Pyrexia	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Cardiac disorders Atrial fibrillation	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Abdominal pain	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Subileus	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations COVID-19 pneumonia	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Infection	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Pneumonia	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Urinary tract infection	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Metabolism and nutrition disorders Dehydration	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 1/8 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 1/8 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Nervous system disorders Brain oedema	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Renal and urinary disorders Acute kidney injury	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Renal and urinary disorders Renal failure	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 1/8 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Pneumonitis	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Rash	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.

Other adverse events

Other adverse events
Measure	Part A: Cohort 1 RO7296682 0.3 mg Q3W n=5 participants at risk Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 0.3 mg IV infusion on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 2 RO7296682 1 mg Q3W n=5 participants at risk Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 1 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 3 RO7296682 2 mg Q3W n=6 participants at risk Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 2 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 4 RO7296682 6 mg Q3W n=14 participants at risk Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 6 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 5 RO7296682 18 mg Q3W n=8 participants at risk Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 18 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 6 RO7296682 35 mg Q3W n=5 participants at risk Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 35 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 7 RO7296682 70 mg Q3W n=15 participants at risk Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 70 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 8 RO7296682 100 mg Q3W n=6 participants at risk Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 100 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 9 RO7296682 165 mg Q3W n=6 participants at risk Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 165 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 10 RO7296682 20 mg Q3W n=6 participants at risk Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 20 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Dyspnoea	40.0% 2/5 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	28.6% 4/14 • Number of events 4 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	46.7% 7/15 • Number of events 8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Epistaxis	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Blister	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Decubitus ulcer	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	13.3% 2/15 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	33.3% 2/6 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	13.3% 2/15 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Excessive granulation tissue	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Exfoliative rash	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 1/8 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Hand dermatitis	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 1/8 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	35.7% 5/14 • Number of events 8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 1/8 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	60.0% 3/5 • Number of events 4 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	46.7% 7/15 • Number of events 7 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	50.0% 3/6 • Number of events 4 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	66.7% 4/6 • Number of events 4 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Purpura	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 1/8 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Rash	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 4 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	35.7% 5/14 • Number of events 9 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	37.5% 3/8 • Number of events 5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	40.0% 2/5 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	26.7% 4/15 • Number of events 9 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	66.7% 4/6 • Number of events 5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	26.7% 4/15 • Number of events 4 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	33.3% 2/6 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 2/8 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 1/8 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Rash vesicular	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 1/8 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Skin toxicity	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Solar dermatitis	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Skin and subcutaneous tissue disorders Vitiligo	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Vascular disorders Flushing	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Vascular disorders Haematoma	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Vascular disorders Hot flush	20.0% 1/5 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Vascular disorders Lymphoedema	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Vascular disorders Hypertension	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 1/8 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Vascular disorders Hypotension	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	33.3% 2/6 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 2/8 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Vascular disorders Jugular vein thrombosis	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 1/8 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Frequent bowel movements	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Blood and lymphatic system disorders Anaemia	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 1/8 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	40.0% 2/5 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 1/8 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Blood and lymphatic system disorders Neutropenia	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Blood and lymphatic system disorders Neutrophilia	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Cardiac disorders Atrial fibrillation	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Cardiac disorders Cardiac failure	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Cardiac disorders Palpitations	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Ear and labyrinth disorders Ear pain	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Ear and labyrinth disorders Tinnitus	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Endocrine disorders Adrenal insufficiency	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Endocrine disorders Hyperthyroidism	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Endocrine disorders Hypothyroidism	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Endocrine disorders Thyroiditis	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Eye disorders Cataract	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Eye disorders Eyelid skin dryness	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Eye disorders Lacrimation increased	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Abdominal distension	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	13.3% 2/15 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Abdominal pain	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 3 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 1/8 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 1/8 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 3/15 • Number of events 4 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Ascites	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 3 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Constipation	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	40.0% 2/5 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	33.3% 2/6 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	14.3% 2/14 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 1/8 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	33.3% 5/15 • Number of events 7 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Diarrhoea	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 1/8 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 3/15 • Number of events 3 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Dry mouth	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Dyspepsia	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 1/8 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Dysphagia	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	33.3% 2/6 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Flatulence	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Lip oedema	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Nausea	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	40.0% 2/5 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	14.3% 2/14 • Number of events 3 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	50.0% 4/8 • Number of events 5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	33.3% 5/15 • Number of events 10 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	33.3% 2/6 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	33.3% 2/6 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Proctalgia	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Metabolism and nutrition disorders Hypokalaemia	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 1/8 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	13.3% 2/15 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Stomatitis	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	13.3% 2/15 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Toothache	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 1/8 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Vomiting	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	35.7% 5/14 • Number of events 7 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 1/8 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	13.3% 2/15 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
General disorders Asthenia	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	35.7% 5/14 • Number of events 6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 1/8 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	13.3% 2/15 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	33.3% 2/6 • Number of events 3 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	33.3% 2/6 • Number of events 3 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
General disorders Axillary pain	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
General disorders Chest pain	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
General disorders Chills	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 2/8 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
General disorders Early satiety	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 3/15 • Number of events 3 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
General disorders Fatigue	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	40.0% 2/5 • Number of events 3 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	33.3% 2/6 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	28.6% 4/14 • Number of events 4 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 1/8 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	33.3% 5/15 • Number of events 11 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	33.3% 2/6 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	33.3% 2/6 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
General disorders Feeling cold	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
General disorders Mucosal inflammation	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
General disorders Nodule	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
General disorders Oedema peripheral	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	13.3% 2/15 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	33.3% 2/6 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
General disorders Pyrexia	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	28.6% 4/14 • Number of events 4 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	25.0% 2/8 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations COVID-19	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 1/8 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Gingivitis	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Localised infection	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Nasopharyngitis	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Oral candidiasis	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Pneumonia	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Postoperative wound infection	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Rash pustular	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Skin infection	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Upper respiratory tract infection	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Infections and infestations Urinary tract infection	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 1/8 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Injury, poisoning and procedural complications Post procedural oedema	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Injury, poisoning and procedural complications Radiation necrosis	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Investigations Alanine aminotransferase increased	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	13.3% 2/15 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Investigations Aspartate aminotransferase increased	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	13.3% 2/15 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Investigations Blood creatinine increased	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Investigations Gamma-glutamyltransferase increased	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Investigations Lymphocyte count decreased	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Investigations Serum ferritin increased	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Investigations Weight decreased	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	14.3% 2/14 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	14.3% 2/14 • Number of events 3 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	40.0% 6/15 • Number of events 9 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	50.0% 3/6 • Number of events 3 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	50.0% 3/6 • Number of events 3 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	21.4% 3/14 • Number of events 3 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	13.3% 2/15 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Groin pain	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 1/8 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Joint stiffness	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Muscle spasms	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	20.0% 1/5 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	21.4% 3/14 • Number of events 4 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 1/8 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	13.3% 2/15 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Pain in extremity	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	33.3% 2/6 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	33.3% 2/6 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour inflammation	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Nervous system disorders Cranial nerve disorder	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Nervous system disorders Dizziness	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	13.3% 2/15 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Nervous system disorders Dizziness postural	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Nervous system disorders Dysarthria	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Nervous system disorders Dysgeusia	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Nervous system disorders Headache	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 1/8 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	40.0% 2/5 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Nervous system disorders Neuropathy peripheral	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Nervous system disorders Paraesthesia	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Nervous system disorders Restless legs syndrome	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Psychiatric disorders Anxiety	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Psychiatric disorders Insomnia	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	40.0% 2/5 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	20.0% 3/15 • Number of events 3 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Renal and urinary disorders Acute kidney injury	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	6.7% 1/15 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Renal and urinary disorders Micturition urgency	20.0% 1/5 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Renal and urinary disorders Pollakiuria	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Renal and urinary disorders Sterile pyuria	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/14 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Reproductive system and breast disorders Pelvic pain	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	40.0% 2/5 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	14.3% 2/14 • Number of events 2 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	12.5% 1/8 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	16.7% 1/6 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	7.1% 1/14 • Number of events 1 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/8 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/5 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/15 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.	0.00% 0/6 • Up to approximately 2 years 7 months Safety population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.

Additional Information

Medical Communications

Hoffman-La-Roche

Phone: 800 821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER

Measure	Part A: Cohort 1 RO7296682 0.3 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 0.3 mg IV infusion on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 2 RO7296682 1 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 1 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 3 RO7296682 2 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 2 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 4 RO7296682 6 mg Q3W n=13 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 6 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 5 RO7296682 18 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 18 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 6 RO7296682 35 mg Q3W n=5 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 35 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 7 RO7296682 70 mg Q3W n=15 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 70 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 8 RO7296682 100 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 100 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 9 RO7296682 165 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 165 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.	Part A: Cohort 10 RO7296682 20 mg Q3W n=6 Participants Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 20 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade \>=4, IRR; Grade \>=4, immune-mediated adverse events; Grade \>=4) were discontinued from study treatment.
Area Under the Serum Concentration Time Curve (AUC) of RO7296682 Cycle 1	12.6 hourmicrograms per milliliter(hμg/mL) Geometric Coefficient of Variation 46.0	46.9 hourmicrograms per milliliter(hμg/mL) Geometric Coefficient of Variation 8.7	104 hourmicrograms per milliliter(hμg/mL) Geometric Coefficient of Variation 33.4	280 hourmicrograms per milliliter(hμg/mL) Geometric Coefficient of Variation 29.5	980 hourmicrograms per milliliter(hμg/mL) Geometric Coefficient of Variation 41.1	1750 hourmicrograms per milliliter(hμg/mL) Geometric Coefficient of Variation 23.2	3940 hourmicrograms per milliliter(hμg/mL) Geometric Coefficient of Variation 29.6	5920 hourmicrograms per milliliter(hμg/mL) Geometric Coefficient of Variation 38.8	10600 hourmicrograms per milliliter(hμg/mL) Geometric Coefficient of Variation 34.4	1040 hourmicrograms per milliliter(hμg/mL) Geometric Coefficient of Variation 22.7
Area Under the Serum Concentration Time Curve (AUC) of RO7296682 Cycle 3/4	26.5 hourmicrograms per milliliter(hμg/mL) Geometric Coefficient of Variation 52.4	39.8 hourmicrograms per milliliter(hμg/mL) Geometric Coefficient of Variation 63.5	109 hourmicrograms per milliliter(hμg/mL) Geometric Coefficient of Variation 7.2	359 hourmicrograms per milliliter(hμg/mL) Geometric Coefficient of Variation 53.6	1140 hourmicrograms per milliliter(hμg/mL) Geometric Coefficient of Variation 26.3	2510 hourmicrograms per milliliter(hμg/mL) Geometric Coefficient of Variation 19.0	5110 hourmicrograms per milliliter(hμg/mL) Geometric Coefficient of Variation 55.1	8070 hourmicrograms per milliliter(hμg/mL) Geometric Coefficient of Variation 49.6	11900 hourmicrograms per milliliter(hμg/mL) Geometric Coefficient of Variation 37.7	1460 hourmicrograms per milliliter(hμg/mL) Geometric Coefficient of Variation 45.2